Leading Voices. Jonathan Montgomery, Chair of the Health Research Authority (HRA) Patient Experience David Corrin My Myeloma Story

Transcription

1 Summer Leading Voices Jonathan Montgomery, Chair of the Health Research Authority (HRA) Patient Experience David Corrin My Myeloma Story Medical MattersMyelo Myeloma NICE guidelines

2 CONTENTS SUMMER 2016 Contents 20 Living well with myeloma This regular feature looks at dealing with pain; planning ahead for the end of life; and things you need to think about when planning a holiday. 8 Research Dr Andy Chantry, Consultant Haematologist at Sheffield Teaching Hospitals NHS Foundation Trust, talks about advances in myeloma bone disease research. 12 Leading Voices Prof Jonathan Montgomery, Chair of the Health Research Authority (HRA), talks about the role of the HRA and the impact it has on patients living in England 14 Medical matters This article explains what the myeloma NICE guideline is and what this means to myeloma patients. 18 Ask the Nurse Ellen Watters, Myeloma Information Specialist at Myeloma UK answers some frequently asked questions, including what anaemia is; when you need to tell the DVLA about your myeloma; and whether it is OK to drink alcohol while on myeloma treatment. 24 Patient experience David Corrin talks about his diagnosis of myeloma, the treatment he has received and the effect the diagnosis has had on his life. PLUS For feedback, comments and questions about content: Contact Sue Perkins on +44 (0) or sue.perkins@myeloma.org.uk To subscribe: Contact Zara Gilmour +44 (0) or zara.gilmour@myeloma.org.uk 2 Myeloma Matters Summer 2016

3 DEAR READER Welcome to the Summer edition of Myeloma Matters. In this issue we are pleased to share details of our MUK seven clinical trial. This trial is the first of its kind anywhere in the world and aims to identify clinical biomarkers that will in turn lead to tests that can identify patients who are likely to benefit from the group of drugs known as immunomodulatory drugs (IMiDs). The trial is a prime example of our commitment to stratified medicine and to a future where every myeloma patient receives the treatments that are most likely to work for them. In addition, we have also been investing in our health services research portfolio. In the past month, we have awarded two research grants, one to the National Institute for Health and Care Excellence (NICE) which will examine the role of patient preference data in the context of the health technology assessment of new treatments, the other to Dr Alberto Rocci, at Manchester Royal Infirmary who will be conducting research into how best to care for frailer myeloma patients. Participation in research is crucial to improving outcomes and quality of life for people affected by myeloma. We owe a huge debt to patients and their families who altruistically take part in myeloma research in full knowledge that many of the benefits will be experienced, not necessarily by them but by patients and families in the future. We firmly believe that the best way to repay this debt is with ethical research that delivers real value to patients. This point is explored in our Leading Voices interview with Prof Jonathan Montgomery. Here, the newly appointed Chair of the Health Research Authority unpacks the role of the regulatory body and how it is developing processes to deliver medical research in the UK in the most effective, efficient and patientcentric way possible. Moving from unpacking to packing, our regular Living well with myeloma feature takes a seasonal look at things to think about if you are planning a holiday abroad. PARTICIPATION IN RESEARCH IS CRUCIAL TO IMPROVING OUTCOMES AND QUALITY OF LIFE FOR PEOPLE AFFECTED BY MYELOMA. Finally, I draw your attention to the achievement of the team of London Paris riders who raised a phenomenal amount of money to support our research programme. Next year s ride is open to registration, it s an incredible experience and a great way to raise funds for research. Spread the word and help us reach our goal to make myeloma history. Best wishes ERIC LOW Chief Executive Follow me on Summer 2016 Myeloma Matters 3

4 NEWS ROUND MUK seven biomarker trial opens Myeloma UK has opened a clinical trial, MUK seven, which is looking at the immunomodulatory drug (IMiD) Imnovid (pomalidomide) in combination with cyclophosphamide and dexamethasone. The trial has been primarily designed to identify clinical biomarkers of response to Imnovid in relapsed and/ or refractory myeloma patients. These biomarkers will enable the development of robust tests aimed at determining which patients are most likely to benefit from Imnovid. MUK seven also aims to strengthen existing evidence which suggests that the combination of cyclophosphamide, Imnovid and dexamethasone improves progression free survival (i.e. the length of time myeloma is in remission) in relapsed and/or refractory myeloma patients, compared with Imnovid and dexamethasone alone. The trial is recruiting 250 patients across the UK, and will provide myeloma patients in England with access to Imnovid where it is currently not approved for use. To find out whether your hospital is participating and to check your eligibility to participate, please speak to your doctor or call the Myeloma Infoline on Dr Martin Kaiser, Chief Investigator of the MUK seven trial said, This trial is hugely important. Understanding which patients are most likely to benefit from specific treatments will help to ensure the right patients get the right treatments at the right time. Myeloma drugs have mixed fortunes in European licensing The European licensing body, the European Medicines Agency (EMA), has made two important decisions about new myeloma drugs. Darzalex (daratumumab) has been granted European marketing authorisation. Darzalex is a new monoclonal antibody which has been licensed for use as a monotherapy (i.e. a treatment which is given on its own) in relapsed and refractory myeloma patients who have previously been treated with a proteasome inhibitor (such as Velcade ) or an immunomodulatory drug (such as thalidomide or Revlimid ). EMA approval means that Darzalex has been judged safe and effective and doctors are now able to prescribe it for patients. However, for it to become routinely available on the NHS it must first be assessed by the UK drug approval bodies. In England and Wales this is the National Institute for Health and Care Excellence (NICE) and in Scotland, the Scottish Medicines Consortium (SMC). Ninlaro (ixazomib) has received a negative recommendation from the Committee for Human Medicinal Products (CHMP), a scientific committee within the EMA. Takeda, the company which produces Ninlaro, has appealed the decision. Eric Low, Chief Executive at Myeloma UK commented, Myeloma UK is extremely disappointed with this decision. We are working with Takeda and the EMA to try and overcome the issues and to gain EMA approval. In the meantime their compassionate use programme for Ninlaro will remain open for patients in the UK and patients can access it via our MUK eight trial. Ninlaro belongs to a group of treatments known as proteasome inhibitors. It is a similar drug to Velcade (bortezomib). If approved Ninlaro would become the first oral proteasome inhibitor to receive a European licence. If the appeal is unsuccessful, doctors will be unable to prescribe it routinely for their patients. The Myeloma UK website will be updated with news about Ninlaro at If you have any questions about the compassionate use programme please speak to your doctor in the first instance. 4 Myeloma Matters Summer 2016

5 NEWSROUND Myeloma UK develops Planning ahead Infopack for patients Myeloma UK has developed an end of life pack for people affected by myeloma in collaboration with specialist palliative care provider Marie Curie. Myeloma UK Service Development Manager Sue Perkins said, Our research has shown that there is a need for better and more meaningful information for myeloma patients about the end of life. The Infopack is intended to be a resource that supplements medical or clinical advice. It draws on the experiences of a range of stakeholders, and we hope that healthcare professionals will find it to be a useful point of reference and support for both themselves and patients. The Infopack includes advice on planning ahead, what to do when treatment is no longer an option and what is meant by end of life and palliative care. The end of life Infopack was produced by Myeloma UK with the support of Marie Curie. It was also reviewed by an expert panel, as well as myeloma patients and their families who shared their personal experiences. You can download Planning ahead: An Infopack for myeloma patients at or a hard copy can be requested by calling the Myeloma Infoline on Revlimid approved in Northern Ireland for restricted use in newly diagnosed myeloma patients The Health and Social Care Board (HSCB) in Northern Ireland has approved Revlimid (lenalidomide) for restricted use in newly diagnosed myeloma patients. Revlimid has been approved, in combination with the steroid dexamethasone, for a subgroup of patients who are both not eligible for high-dose therapy (HDT-SCT) and cannot have thalidomidebased treatment due to peripheral neuropathy (i.e. where the hands and feet are affected by nerve damage). The HSCB decision means it will be made available in this setting for myeloma patients in Northern Ireland, subject to paperwork being completed by a myeloma doctor on a case-bycase basis. The decision in Northern Ireland follows approval of Revlimid in this setting in Scotland in December The drug approval body in Wales, will be assessing Revlimid in July and it is likely that Celgene, the manufacturer of Revlimid, will make a submission to the drug approval body in England in the coming weeks. Myeloma Matters readers survey Thank you to the 426 Myeloma Matters readers who completed our recent survey about the magazine. This was an excellent response and will give Myeloma UK lots of information and suggestions about how to improve the magazine so that it better meets your needs. We are still analysing the results but the main feedback shows us that: As expected, the highest percentage of survey respondents were myeloma patients (79%), followed by relatives or friends of a myeloma patient (16%) and then healthcare professionals (5%) Our readers are most interested in updates on myeloma treatments, followed by information about myeloma symptoms and complications and side-effects of treatment and then articles about how to live well with myeloma e.g. diet, exercise, complementary therapies, travel, finances etc 93% of survey respondents said that Myeloma Matters has helped them or someone close to them better understand myeloma Most survey respondents indicated that reading Myeloma Matters makes them very likely to contact Myeloma UK for information and support and to say that Myeloma UK is an organisation that understands their needs Understandably for a printed publication, most survey respondents said that they prefer receiving information through newspapers, magazines, leaflets and direct mailings rather than newsletters, websites or social media e.g. Facebook or Twitter We are still analysing the results of some questions and will report these in more detail in our Autumn issue, but are delighted that so many of you took the time to give us feedback. Thank you to everyone who took part. Summer 2016 Myeloma Matters 5

6 MYELOMA SCOPE MYELOMA RESEARCH NEWS FROM AROUND THE WORLD 6 Myeloma Matters Summer 2016

7 MYELOMASCOPE Darzalex continues to show promise in myeloma Initial findings from two large Phase III clinical trials have demonstrated positive results for the monoclonal antibody Darzalex (daratumumab) in relapsed and/or refractory myeloma. The CASTOR clinical trial involving relapsed and/or refractory myeloma patients has shown that the addition of Darzalex to Velcade (bortezomib) and dexamethasone reduced the risk of disease progression by 61%, and doubled response rates compared with the standard combination alone. In similarly impressive results, the POLLUX trial, involving the addition of Darzalex to Revlimid and dexamethasone, reduced the risk of disease progression by 63% compared to Revlimid and dexamethasone alone. More information on these trials will be presented in the conference report to accompany the next issue of Myeloma Matters. Isatuximab shows potential in higher risk myeloma The anti-cd38 monoclonal antibody isatuximab is showing potential as a monotherapy (used on its own and not in combination with other drugs) in the classically higher risk groups in elderly patients and those with high-risk cytogenetics (genetic factors associated with poorer outcomes). In the Phase II trial of 97 patients who had, on average, received five prior treatments, the response rate was 46.2% in patients aged 70 years or older and 38.1% in patients with high-risk cytogenetics. Isatuximab is also being studied in a number of other myeloma trials which will add to the body of evidence supporting its use in myeloma. White light reduces some symptoms and complications of myeloma A series of small randomised controlled trials in the United States has investigated the use of white light (colourless light, e.g. daylight) to reduce some of the sideeffects of cancer including extreme fatigue and feelings of depression. The trial included myeloma patients. 54 cancer patients participated in the latest trial where half of them were exposed to white light, by sitting next to a special light box, and the other half were exposed to dim red light as a control group for the trial. Early data suggests that the patients exposed to white light reported significant improvements in relieving feelings of depression whereas the patients receiving dim red light reported no change. An earlier study of 36 cancer patients also found that exposure to white light helped them to feel less fatigued. Bright light is known to treat several conditions, including Seasonal Affective Disorder (SAD) and jetlag. It is not fully understood why light helps some cancer patients; to investigate this, researchers are now beginning a five year trial involving 200 patients at two centres in New York focusing on fatigue, depression and sleep problems in cancer patients. Trial looks at genetic link and survival in myeloma A trial recently published in the journal Nature Communications has looked at genetic markers associated in survival in myeloma. The research was performed at The Institute of Cancer Research (ICR) and funded by Myeloma UK. It looked at the genotype (part of the DNA sequence) from four genome-wide association studies (GWAS) involving nearly 3,000 myeloma patients. GWAS look at many genetic variants in different individuals to see if any variant is associated with a trait, for example survival. The trial found that a variation at a single position in DNA was commonly found in each of the four GWAS, and this has been associated with myeloma survival. More research is required to identify similar genetic patterns, but the researchers concluded that these genetic markers associated with myeloma survival have the potential to identify high-risk and low-risk myeloma patients. This in turn may help to identify which myeloma treatments will be most effective in these subgroups of patients. New recommendations for the diagnosis and management of myeloma-related renal impairment The International Myeloma Working Group (IMWG) has published updated recommendations on diagnosing and monitoring myeloma-related kidney (renal) impairment. The guidelines recommend that all patients should be assessed for renal impairment (whether or not they have any symptoms) at diagnosis and at each subsequent follow-up visit. Patients are currently assessed for myeloma-related renal damage at diagnosis through creatinine and urea tests, and most patients will also receive an estimated glomerular filtration rate test. The recommendations state that patients should now also receive free light chain and electrophoresis of a sample from a 24-hour urine collection. Keep up-to-date on myeloma news by visiting or sign up to our monthly e-newsletter at Summer 2016 Myeloma Matters 7

8 ADVANCES IN MYELOMA BONE DISEASE RESEARCH BY DR ANDY CHANTRY Consultant Haematologist, Sheffield Teaching Hospitals NHS Foundation Trust This article discusses what myeloma bone disease is, how it is treated and managed and what is happening in regard to its research. Cause of myeloma bone disease Myeloma bone disease is the most common and often the most debilitating complication of myeloma. It is caused by the myeloma cells in the bone marrow, through a complex signalling network, which affects the surrounding bone, causing it to be broken down faster than it can be repaired. Healthy bone is not static and fixed, it is in a constant state of remodelling which allows for minor areas of damage to be repaired and to maintain the strength and structure of the bone. Bone remodelling is a process to sustain a continuous cycle of bone formation and breakdown which keeps the bone in a constant state of renewal. Two very important types of cell which play a key role in this process are: Osteoclasts (cells which break down old bone) Osteoblasts (cells which form new bone) Normally, the rate of bone formation and the rate of bone breakdown are equal, so that the bone mass remains the same. However, in myeloma the process is imbalanced, osteoclast activity is increased and osteoblast activity is decreased which results in a net loss of bone. It can cause significant damage to the major bone marrow containing bones which most commonly include the middle or lower back, the hips and the rib cage. The long bones of the upper arm and leg, and the shoulder may also be involved, resulting in thinning, lytic lesions (holes in the bone), compression fractures (caused by weakening of the bone not impact or trauma) and hypercalcaemia (a higher than normal level of calcium in the blood). How is myeloma bone disease detected? The standard method of detecting bone disease is the skeletal survey which is a collection of X-rays covering the skull, spine, rib cage and pelvis. However, through better imaging techniques, it has been identified that X-rays can miss areas of myeloma-related bone damage. X-rays do identify lytic lesions in patients with myeloma but it is estimated that between 30-50% of bone has to have already have been lost before these areas of damage can be detected on X-rays. This means that more sensitive imaging techniques are required in myeloma to detect bone damage as early as possible. Recent guidelines from the National Institute for Health and Care Excellence (NICE), the public body responsible for assessing the clinical and cost-effectiveness of new drugs or treatment combinations for use on the NHS in England and Wales, recommended that more sensitive imaging techniques such as CT, MRI and PET/CT should be used to better identify bone damage and improve outcomes for patients as first-line imaging. Current treatments for myeloma bone disease In most cases, myeloma bone disease is likely to be an ongoing issue, but treatments are available to slow down its activity, reduce symptoms and sometimes prevent and/or correct the complications that occur as a result. Bisphosphonates and other bone strengthening treatments It is recommended that all myeloma patients should receive bisphosphonate treatment, usually zoledronic acid (previously known as Zometa) which is given once a month as an intravenous infusion, normally when patients are receiving anti-myeloma treatment. Patients are normally given bisphosphonates for a minimum of two years, although length of treatment can vary between hospitals. Anti-myeloma treatment Treatment of the myeloma itself is one of the most effective ways of controlling myeloma bone disease, correcting hypercalcaemia and relieving pain. It is also thought that some of the drugs used to treat myeloma such as the immunomodulatory drugs i.e. Revlimid (lenalidomide) and thalidomide are thought to inhibit osteoclast activity, and so reduce the 8 Myeloma Matters Summer 2016

9 MYELOMA RESEARCH rate at which bone is broken down. Evidence also suggests that Velcade (bortezomib), a type of proteasome inhibitor drug, has bone remodelling properties and can increase bone formation. Radiotherapy Radiotherapy can be very effective in myeloma bone disease at providing localised pain relief. Surgery It is common for myeloma patients to have compression fractures and it may be necessary for patients to be referred to an orthopaedic surgeon to fix fractures and strengthen damaged bone by preventative fixation and stabilisation procedures, and to prevent further damage to other at risk bones using a variety of pins, screws and other fixation procedures. It is important that myeloma bone disease is diagnosed early to minimise damage. If existing damage is identified, patients should be referred to orthopaedic surgeons. There are two main surgical procedures used in myeloma bone disease: Percutaneous Vertebroplasty: This involves injecting bone cement into collapsed or damaged vertebrae (the bones that make up the spine) in order to improve strength of the damaged vertebra. Percutaneous Vertebroplasty can also relieve pain where standard pain relief has failed, improve mobility and reduce the risk of spinal cord compression. Balloon Kyphoplasty: Similar to Percutaneous Vertebroplasty, Balloon Kyphoplasty involves reshaping the vertebrae using an inflatable balloon tamp before filling with bone cement. Pain relief It is essential that adequate pain relief underpins the treatment of myeloma bone disease. Simple pain-killers such as paracetamol can be effective, however stronger opiate based painkillers are available as tablets, liquids and slow releasing skin patches. Other more specialist pain-killers which are effective in relieving bone and nerve pain, such as pregabalin are also available to patients. Future treatments for myeloma bone disease While bisphosphonates do slow down myeloma bone disease, they do not altogether prevent it and do not repair existing damage. They can cause a range of side-effects including damage to the kidneys, nausea and feeling achy. New and better treatments are therefore needed. CT, MRI and PET/CT scans CT, MRI and PET/CT scans are the basis of the imaging tests in myeloma. These scans provide more detailed images of the bones and they can also be used to pinpoint the exact area where radiotherapy treatment is to be given. They are increasingly being used to guide treatment of myeloma bone disease. The amount of radiation used in some of these scans is greater than for an X-ray, but is more sensitive and can determine the presence or absence of myeloma bone disease more accurately. Anabolic agents A class of drugs known as bone anabolic agents are being investigated as a potential treatment approach for myeloma bone disease. Anabolic agents work by building up bone, and early data from the laboratory show that they may offer a substantial improvement over bisphosphonates and begin to repair the damage. There is also promising data on bone anabolic agents in combination with current bisphosphonates. Monoclonal antibodies Denosumab is a type of drug known as a monoclonal antibody which has been designed to specifically detect and attach to a protein called RANKL which is produced by osteoblasts. By attaching to RANKL, denosumab reduces bone breakdown. A Phase III clinical trial involving myeloma patients reported in 2011 that denosumab was not as toxic to the kidneys as zoledronic acid, and therefore it may be suitable for patients with poor kidney function. However, the trial did not demonstrate that denosumab was more effective than zoledronic acid in delaying the time to skeletal-related events (such as bone fractures, spinal cord compression or need for radiotherapy); rather, it found that denosumab performed similarly to zoledronic acid. Denosumab is still being further investigated and it is only available through a clinical trial at the moment. There is now an ongoing myeloma trial which is comparing denosumab with zoledronic acid in newly diagnosed patients. Researchers are also investigating the action of another monoclonal antibody drug on a signalling pathway important for normal bone development. Results to date have shown that myeloma cells secrete a protein called DKK-1 which is linked to the function of osteoblasts, but DKK-1 is not detected in healthy cells. Higher levels of DKK-1 are linked to higher levels of lytic lesions and bone damage. So by developing a monoclonal antibody, which will bind to DKK-1, researchers hope this will block its action and reduce lytic lesions and bone damage. Btk inhibitors Many treatments being investigated in myeloma bone disease are still being developed in the lab. One of these compounds is a Bruton s tyrosine kinase (Btk) inhibitor which is an enzyme that modulates B-cell (cells which form a key part of our immune system) development and plays an important role in antibody production. CC-Btk when combined with Kyprolis, a drug used to treat myeloma in mice shows significant results. It inhibited the function of osteoclasts and also increased bone volume. Summary Many of the new myeloma bone disease treatments discussed above, are becoming increasingly recognised as more effective treatments than bisphosphonates. Targeting the cell signalling network/process in the bone microenvironment, specifically bone formation, is a particular area of interest and more clinical trials are required to investigate these new drugs, on their own and in combination with existing bone disease treatment. Summer 2016 Myeloma Matters 9

10 Measuring quality of life in myeloma an interview with Christina Ramsenthaler Christina Ramsenthaler is a researcher based at the Cicely Saunders Institute in London. In this interview Christina talks about the Myeloma Patient Outcome Scale (MyPOS). The MyPOS is a new questionnaire developed from the research at the Cicely Saunders Institute into how to measure quality of life in myeloma in day-to-day clinical practice. The research was supported by a Myeloma UK Health Services Research Grant. What was your research about? This study was about developing a new questionnaire to assess quality of life of myeloma patients. The MyPOS questionnaire was designed to be used in clinical practice to support myeloma patients and their doctors and nurses to focus on what is most important to the individual patient. Why is quality of life important to measure in myeloma? Quality of life encompasses all aspects in a person s life that contribute to their wellbeing. For example, our study has shown that the impact of myeloma on quality of life does not only concern physical symptoms but also emotions, relationships with family and friends, financial security and spiritual wellbeing. We also know that myeloma patients experience different symptoms and problems to patients with other cancers. To make doctors and nurses aware of these wider issues, it is important to have a reliable way to regularly assess them. Why is it difficult to measure quality of life? Quality of life is hard to capture and measure. Not only do we all have a different perception of what it means, but this perception might also change over time as we adapt to what happens to us in our lives. Things that once were important might not be important anymore when we are faced with illness and/or undergoing chemotherapy treatment. For it to work well, a questionnaire has to ask about a list of things that is the same for everybody. The MyPOS captures the common themes and topics that came out of our interviews with patients. However, we also included questions that allow patients to describe the issues they are experiencing in their own words. Why do we need a myeloma-specific questionnaire? Many of the existing quality of life questionnaires contain questions that are relevant for a variety of cancers but are not myeloma-specific. When we compared what was in existing questionnaires with what people with myeloma had told us, we found that no existing questionnaire captured all the important aspects to myeloma patients. Existing questionnaires are also generally designed for research purposes and fairly lengthy, and are not designed to support clinical/ holistic decision-making. This meant that there was not a questionnaire that could be reliably used in clinical practice to capture what matters to myeloma patients. How did you go about developing the MyPOS questionnaire? First we needed to understand what quality of life means and how having myeloma and undergoing treatment impacts on people s quality of life. We asked myeloma patients to describe what brings quality to their lives and how having myeloma affects it. We then showed patients some existing quality of life questionnaires to find out about the type of questions and layouts they preferred. We also interviewed doctors and nurses about what they wanted to see from a quality of life questionnaire. On the basis of this we designed the MyPOS. We deliberately kept it short (it takes 7 minutes to complete on average) and it contains many of the 10 Myeloma Matters Summer 2016

11 SPECIAL FEATURE MUK RESEARCH GRANT SPOTLIGHT important aspects missing from other questionnaires. After testing and refining it we worked with 14 hospital trusts in England and 380 patients who helped fill in the questionnaire. This process is called validation. The results showed that the questionnaire worked as intended. They also showed that patients found it easy to complete and that it provided valuable information to their doctors and nurses. We learnt that the MyPOS was useful for all situations: it was able to capture important issues no matter what type of treatment or problems patients were experiencing. We also looked at how well the MyPOS can measure changes in quality of life over time, for example as patients progress through different treatments and treatment-free intervals. We therefore did a second large survey in which we sent patients repeat questionnaires every two months. From this study we know that the MyPOS is able to track important changes over time. What did your team find most interesting in carrying out the research? We were touched by the open discussions and in-depth interviews we had with patients sharing how their quality of life had been affected by myeloma. We learnt that it often was not a symptom in itself that bothered them, but more when the symptom hindered them from doing what they want or enjoy. We took care to incorporate this in the questionnaire. We were touched by the open discussions and in-depth interviews we had with patients sharing how their quality of life had been affected by myeloma. Is the MyPOS questionnaire ready to be used now? Yes, the MyPOS questionnaire can be downloaded from our website, We ask people to register but registration is free. What are the benefits of using the MyPOS questionnaire? The MyPOS is a questionnaire that has been developed by myeloma patients for other myeloma patients. It has been shown to comprehensively capture the impact of myeloma and treatment on a person s quality of life. It can be used to help patients in consultations with their doctors and nurses to identify those areas that need specific care and attention. It may also help understand the impact of new myeloma treatments going through clinical trials. What is next for you and for the MyPOS research? Now that the questionnaire development has finished, we would like to see the MyPOS used in haematology clinics. We also intend to further study how using this questionnaire in consultations helps patients, their families and doctors and nurses. Alongside this we would also like to develop training for doctors and nurses about how best to support those patients whose answers to the MyPOS indicate a need for more support. Quality of life is such an important issue and we hope our research has produced a useful tool that will help both patients and their doctors and nurses to focus on making important improvements. Download the MyPOS at Find out more about this and other Health Services Research Myeloma UK is supporting by ing Research@myeloma.org.uk 2016 FOR PATIENTS & FAMILIES BIRMINGHAM 10 September NEWCASTLE 24 September CARDIFF 8 October MANCHESTER 5 November LONDON 19 November To register or for more information visit or call Summer 2016 Myeloma Matters 11

12 LEADING VOICES Leading Voices features short interviews with key opinion leaders from government, industry, the NHS and the myeloma community. Prof Jonathan Montgomery, a Professor of Healthcare Law at the University of Southampton, is the current Chair of the Health Research Authority (HRA). In this interview, we ask him about the role of the HRA and the impact it has on patients in England. QWhat is the Health Research Authority (HRA)? Why was it established? AThe HRA is an NHS organisation, originally created in 2011 and is now a statutory body under the Care Act It was established in response to a report from the Academy of Medical Sciences (an independent body representing medical science in the UK) that identified key barriers to efficiently setting up research in the UK. These were barriers that were letting patients and researchers down and holding back the UK s contribution to medical advances. QWhat is the role of the HRA in health research and research ethics? AHealth research is very important for improving outcomes for patients with particular conditions as well as the nation s health overall. Our role at the HRA is to help make the process for taking part in health research as simple as possible for everyone involved. A big part of this is coordinating the process across England for health research to be ethically reviewed and approved. This is a really important requirement of all health research as it makes sure that patients and others are provided with the information they need to help them decide whether to take part in research and that all important issues that could be of concern to participants are considered before the research begins. This helps build confidence in research and makes sure that research is the best it can be. QHow does the work of the HRA relate to/impact on patients with cancer such as myeloma? All patients rely on the fact that A their doctors and nurses have a good understanding of their disease and that they have options to at least improve their prognosis and where possible cure them. We need to improve those options and medical research is a key part of that. The HRA does not carry out that research itself, but it aims to ensure that the UK is a great place to do ethical research and make it easy for good research to be done. QWhy did you take on the role of Chair at the HRA and what does your role involve? AI decided to take on the role of Chair as I wanted to be part of the solution to the problems identified by the Academy of Medical Science s report and work towards a more efficient health research environment. I devote part of my working life to academic work as Professor of Health Care Law at University College London and part of it to involvement in the NHS. Having spent over 15 years chairing various local NHS organisations in Hampshire, I wanted to look for something that would make a difference to healthcare and research at a national level. Q How do you promote the interests and needs of patients in UK health research? We aim to make sure that A research is carried out ethically and in a transparent way so that we get the best possible returns from the investments that everyone puts in. Patients invest their time, and in a way their bodies, to the enterprise of health research. They are entitled to expect that we do not waste the opportunity they have created to learn more about care and treatments. Research funders don t want their money diverted into bureaucracy. Researchers want to spend as much time and energy as they can on searching for answers. It is our job to ensure that regulation is proportionate and not an unnecessary restriction on people s opportunities to participate in research or benefit from its results. Q A What is research ethics and why is it important? Research ethics developed because the desire to drive 12 Myeloma Matters Summer 2016

13 LEADING VOICES science forward did not always take proper account of the interests of participants. That remains important, but it is not the only concern of research ethics. We want to make sure that all trials are registered, so that knowledge is not lost. Too many studies do not produce published results and that is a terrible waste. We have made registration a condition of ethical approval. We also need to encourage researchers to involve communities such as those affected by myeloma in the design of research, so that they appreciate how much better research is when done in collaboration with those who really care about the results. Q From your perspective, what does good health research look like? As a minimum good health A research will be ethical and scientifically sound otherwise it cannot actually contribute the knowledge we need. Importantly, however, it also needs to address the issues that are important for patients, not just scientific curiosity. Sometimes the way in which benefits are measured do not really relate to the things that matter to patients that is easily fixed if they are involved in the development and design of projects and clinical trials. Sometimes the priorities for research seem more related to the interests of scientist or drug companies that the needs of patients for therapies. The better our research system, the better the alignment of these things would be. In the end good research is all about making our health care better; saving and improving lives. Q What are the main challenges in designing and conducting clinical trials and other research for a rare cancer like myeloma? A Scientific design is not my area. In general, the rarer the condition, the more difficult it is to get the numbers required to be confident that the results of trials are reliable and not merely down to chance. That means it is complicated to organise the trials that we need, and it can take a lot of time and effort to draw together all the different organisations that need to be involved in the conduct of the trials. The HRA was set the task of making this easier. A lot of work has taken place Q to streamline the approvals process for medical research and ethics across the UK. What do you think the key achievements have been for the HRA? The basic principle is that we A should only do things once, not repeat them. So where some form of check is required the HRA can ensure that this is done and provide the organisations that are hosting the research with confidence that it is appropriate for them to do so. So we only need one ethics committee review per study, not one for every hospital (as was previously the case). We don t need to spend money on lawyers drawing up different legal contracts between drug companies and every single NHS organisation we can have a standard form. Pharmacy reviews of protocols can be done once and shared. We now have a system that has enabled this principle to be applied for a study being carried out in every NHS Trust in the country. We are proud of that and we think it will speed up the process of getting trials started. Q Conversely, are there any further improvements that need to be made to improve the system? There is always more that can be A done, and it is still early days for our new HRA Approval Service. We need to do more to enable the opportunities of NHS records to be made available to researchers so we can find out more about how treatment works in ordinary clinics not just in trials. This means ensuring that we take care over people s privacy so that they feel confident in supporting such research. We need to identify barriers to the research that people need to see begin carried out and see if we can dismantle or overcome them. Those most affected by the health problems need to be at the centre of that process, so organisations like Myeloma UK are central to setting the agenda. Q What are the HRA s main priorities for the rest of 2016 and beyond? We are working on longer term A priorities and would welcome suggestions. For 2016 we want to consolidate our new approvals system and check that we do actually get the benefits that it is designed to deliver. You can get caught up in change for its own sake. We are determined that this is change for a purpose. We are reviewing the feedback on the new policy framework for research, which we hope to publish in the summer. That will focus our system on helping people do good and ethical research, not on worrying about whether to permit it. Then we need to make sure we take full advantage of legal changes to the European Clinical Trials Regulation, so that the UK is a research powerhouse. There is plenty to do. Q What would you like your legacy to be? I would like researchers to think A that regulation enables them to do their job better. For participants to be confident that their contributions are not being wasted and that they are equal partners in research that they think is really worth doing. Ultimately, I would like the UK to have been able to take the lead in improving the treatment of myeloma because the HRA has provided robust and constructive regulation that helps high quality research be done safely, ethically, and for the maximum benefit to us all. For more information about the work of the Health Research Authority, visit Summer 2016 Myeloma Matters 13

14 WHAT DOES THE MYELOMA NICE GUIDELINE MEAN FOR ME? BY LOIS LOBBAN Patient Information Specialist, Myeloma UK This article explains what the myeloma NICE guideline is and what this means to patients. 14 Myeloma Matters Summer 2016

15 MEDICAL MATTERS In February 2016, the National Institute for Health and Care Excellence (NICE), published guidance on the diagnosis and management of myeloma, including smouldering myeloma and plasma cell leukaemia (a rare type of cancer arising from plasma cells). NICE is the public body responsible for assessing the clinical and costeffectiveness of new drugs or treatment combinations for use on the NHS in England and Wales. The publication of this guideline by NICE is significant for myeloma patients as it provides evidence-based recommendations for the diagnosis and management of myeloma which, as far as possible, aims to standardise the treatment and care of myeloma patients across the UK. What is a NICE guideline? NICE guidelines give recommendations on how healthcare professionals should care for patients with specific conditions or illness; the guidelines are also important for health service managers and people within the NHS who commission (plan and buy) health services. The guidelines can cover recommendations about: Treatment by GPs and other community-based care (primary care) Treatment by or in hospital (secondary care) Treatment in specialist services (tertiary care) The recommendations in all NICE guidelines are based on the best available evidence. What is the myeloma NICE guideline? The myeloma NICE guideline is the first NICE guideline to be published which directly relates to the treatment and management of myeloma patients. It aims to improve care for myeloma patients by promoting the most effective tests and treatments for myeloma and its complications. The guideline was developed by a group of patients and healthcare professionals, including Monica Morris, Clinical Nurse Specialist and Healthcare Professional Programme Manager at Myeloma UK. It includes a range of best practice recommendations for myeloma patients in England and Wales. Unlike NICE technology appraisals (recommendations on the use of new and existing medicines and treatments within the NHS), the guideline is not binding for health bodies. However it does guide best practice including prevention and management of complications and side-effects of myeloma, which impacts on patients' quality of life, and is not covered by existing NICE guidance. Importantly, this guideline also recommends providing individual information and support to patients, families and carers at all stages of the pathway. Some themes from the key recommendations in the guideline include: 1. Information and support 2. Laboratory investigations 3. Imaging investigations 4. Service organisation 5. Managing newly diagnosed myeloma 6. Managing acute renal disease caused by myeloma 7. Preventing and managing bone disease 8. Preventing and managing complications 9. Monitoring 10. Managing relapsed myeloma Information and support The NICE guideline recommends that healthcare professionals should provide information and support to myeloma and plasma cell leukaemia patients and their family members, particularly at diagnosis, at the start and finish of new treatments, at relapse and at end of life. Healthcare professionals should provide information on an individual basis where possible. Laboratory investigations Serum protein electrophoresis and serum free light chain assay tests should be used to determine paraprotein in all patients suspected of having myeloma or monoclonal gammopathy of undetermined significance (MGUS). Healthcare professionals should also use only one bone marrow biopsy so that different tests can be done from a single sample without the need for several samples which can be painful for patients. Imaging investigations Healthcare professionals should offer imaging tests to all patients suspected of having myeloma. The guideline states that they should consider a whole-body MRI scan as first-line imaging or low-dose whole body CT scan for patients who are not suitable for an MRI or patients who decline it; however not all hospitals have the scan machines required for these imaging tests. Service organisation The guideline recommends that every hospital treating myeloma patients who are not receiving chemotherapy or high-dose therapy and stem cell transplant (HDT-SCT) should have access to coordinated supportive care such as: A multidisciplinary team (MDT) specialising in myeloma Supportive and palliative care teams supported by other services such as psychological, physiotherapy, occupational therapy support services Access to clinical trials All hospitals should also provide access to other specialist services such as renal (kidney) and pain specialists Managing newly diagnosed myeloma Revlimid (bortezomib) is recommended in combination with dexamethasone or dexamethasone and thalidomide for previously untreated patients who are eligible for HDT-SCT as an initial treatment. Or thalidomide and an alkylating agent such as cyclophosphamide or melphalan for patients who are not eligible for HDT-SCT. Summer 2016 Myeloma Matters 15

16 The guideline also states that broader criteria need to be considered to determine if a patient is eligible for HDT-SCT or not. Managing acute renal disease caused by myeloma For newly diagnosed patients who have myeloma-related renal damage, healthcare professionals should begin a treatment combination which includes Velcade (bortezomib) and dexamethasone. Preventing and managing bone disease The myeloma NICE guideline states that bone disease should be prevented by offering all patients bisphosphonates, specifically zoledronic acid, disodium pamidronate or sodium clodronate. Radiotherapy should also be considered for patients who have non-spinal bone damage specifically if bone(s) have fractured or are at risk of fracturing. Preventing and managing complications The guideline outlines how healthcare professionals should prevent and manage some of the symptoms and complications of myeloma and its treatments, such as preventing infection, managing peripheral neuropathy, preventing thrombosis and managing fatigue. Monitoring The guideline states that patients with smouldering myeloma should be monitored every three weeks for the first five years. It also stated that patients should be monitored at least every three months after treatment with a series of laboratory tests including a full blood count, renal function test, bone profile, serum protein electrophoresis and serum free light chain assay tests. Managing relapsed myeloma The guideline states that at relapse healthcare professionals should consider several treatment options including Velcade monotherapy (given on its own) at first relapse, if the patient has received one prior therapy and is not suitable for HDT- SCT, or a second HDT-SCT for eligible patients. How was the guideline developed? NICE guidelines are developed by a range of stakeholders who are affected by the guidelines' recommendations; and form the guideline committee, including consultant haematologists, nurses, myeloma patients, carers, commissioners and national private, public and voluntary sectors. The guideline is then scoped by the committee to determine if it is required and what it intends to achieve. If the guideline is taken forward, stakeholders carry out a literature search and an evidence search which collects all available and suitable evidence to support the guideline recommendations. Once the guideline is drafted it is reviewed and amended, often several times before it is published. From scope to publication it typically takes between months to produce a NICE guideline. How does the NICE guideline affect me? All NICE guidance and recommendations by NICE applies to the NHS Health Boards in England and Wales. Scotland and Northern Ireland are governed by different organisations the Scottish Medicines Consortium (SMC) in Scotland and the Department of Health, Social Services and Public Safety in Northern Ireland. The guideline aims to achieve equity in the diagnosis, management and monitoring of myeloma patients across the UK. Healthcare professionals in England and Wales are expected to consider the recommendations of the guideline when making clinical decisions for patients. There may be times when the guideline is not appropriate for some patients, and healthcare professionals may have to make decisions about treatment and care that go against the guideline recommendations. If this does happen, healthcare professionals must record their reasons for deviating from the guideline. The myeloma NICE guideline is one of a number of guidelines which are all aimed at improving and standardising the treatment and care myeloma patients receive on the NHS. This is a very important aim, however, as guidelines are not mandatory (compulsory) not all of their recommendations will automatically be implemented or adopted locally in hospitals. Implementing guidelines may require hospitals to invest in staff or other resources, for example making sure that certain scanning equipment is available and that there are enough appropriately trained staff to operate the equipment. Not all hospitals will have the finances or staff to meet all of the guideline recommendations straight away. Myeloma UK has developed a programme called the Clinical Service Excellence Programme (CSEP) which aims to measure whether guidelines are making a positive impact on patient and family experience of care and to collect and share examples of best practice in hospitals, whether this is in meeting guideline recommendations or through other service improvements. CSEP has been piloted in a number of hospitals and will be rolled out to additional sites this year. Sue Perkins Service Development Manager Myeloma UK For more information about the myeloma NICE guideline and how it affects you, call the Myeloma Infoline on or visit 16 Myeloma Matters Summer 2016

17 RESEARCH Myeloma UK establishes two new Health Services Research Partnerships As part of our strategy to highlight patients' needs and preferences Myeloma UK has awarded funding for two new research studies designed to help improve patient outcomes, wellbeing and quality of life. How were the studies selected for awards? Applications for our Health Services Research grant competition were reviewed by external advisors, patients and carers as well as a committee of the Myeloma UK Research Advisory Group. The successful studies were chosen on the basis of the quality of the submitted proposal, the relevance of the research, potential to benefit patients and value for money. Here you can find out more about the two studies we are supporting. Prof Sarah Garner, National Institute for Health and Care Excellence (NICE) Methods for patient-centred decisionmaking on the availability of new treatments. Funding will support a new type of study at NICE that aims to improve the way patient perspectives can influence decisions about the availability of new treatments. Decisions by Health Technology Assessment (HTA) bodies such as NICE have a huge impact on the myeloma patient community, as they determine which treatments patients and their clinicians have access to. However, there is no agreement about how best to understand, capture and use patient perspectives alongside other types of evidence and discussions about the cost of new treatments. This study will explore how best to capture information about patient preferences relating to their condition and treatments. It will be undertaken in consultation with patient groups, experts and other leading HTA bodies across the world. Myeloma UK hopes this study will improve the influence of patients views in decisions about which treatments are made available and ultimately improve access to effective myeloma treatments. Dr Alberto Rocci, Myeloma Lead at Manchester Royal Infirmary Improving the outcomes of frailer myeloma patients. To date there has been very little research into how best to care for frailer myeloma patients. This realworld study based at Manchester Royal Infirmary will look for signs of frailty by conducting tests and look at things like how long it takes a patient to walk a certain distance. After collecting and analysing patient data, they will develop a simple screening test to help assess and monitor patients at risk of frailty. By exploring new ways to prevent and manage the impact of frailty, Myeloma UK hopes the study will help ensure patients who are frail or at risk of becoming frail have much better outcomes. Carers share perspectives on life with myeloma Thank you to the more than 350 carers and family members who took part in our Who Cares? Myeloma family and friends survey in May. This was our biggest ever survey of friends and family members. The survey will highlight the important role that friends and family members play in supporting myeloma patients and help Myeloma UK make sure that carers are getting the support that they themselves would find helpful. The second part of the study is now underway and we look forward to sharing our findings from this project in Autumn. To receive a link to the final report as soon as it is available research@ myeloma.org.uk or call For information on our research programme, visit: research Or sign up to our monthly e-newsletter: enewsletter

18 ASK THE NURSE Ellen Watters RGN Myeloma Information Specialist, Myeloma UK Myeloma UK receives many questions from patients and family members about myeloma and its treatment and care. These come from many places, including the Myeloma Infoline, at Infodays, the online Discussion Forum and Support Groups. In each edition of Myeloma Matters Ellen answers a selection of the most frequently asked questions. 18 Myeloma Matters Summer 2016

19 ASK THE NURSE What is anaemia? Anaemia is a very common complication of myeloma. It is present in more than 60% of patients at diagnosis. Symptoms of anaemia can include: shortness of breath, especially on exertion, feeling dizzy or light headed, extreme tiredness and pallor. Myeloma can cause anaemia in two ways: by directly interfering with the production of healthy red blood cells (which carry oxygen around the body in the form of haemoglobin) in the bone marrow; and as a result of myelomarelated kidney disease. In response to low levels of red blood cells, the kidneys produce a hormone called erythropoietin (EPO) which then boosts red blood cell production. If kidney function is impaired as it sometimes is in myeloma - then the ability to produce EPO may also be impaired and this is why myeloma patients with kidney damage are more likely to be anaemic. Anaemia is monitored for routinely in patients and is identified when blood tests show a low level of haemoglobin. Normal levels of haemoglobin are 130 to 170 g/l (13 to 17 g/dl) for men and 120 to 160 g/l (12 to 16 g/dl) for women this can vary somewhat between laboratories. Anaemia caused by myeloma usually improves when the myeloma responds to treatment. However, we also know that some of the treatments for myeloma can temporarily cause a reduction in red blood cells; again this will be monitored and should improve once treatment is finished. Severe anaemia or symptomatic anaemia can be managed with blood transfusions or by giving injections of EPO. EPO is generally used in anaemic patients who have reduced kidney function. When do I need to tell the DVLA about my myeloma? You must tell the DVLA if you have a driving licence and: You develop a notifiable medical condition or disability A condition or disability has got worse since you got your licence Notifiable conditions are anything that could affect your ability to drive safely. They can include physical disability and visual impairment as well as conditions such as stroke and epilepsy. Myeloma isn t specifically on the DVLA list of notifiable conditions but recently the DVLA has announced that patients who develop peripheral neuropathy need to inform the DVLA about this. Peripheral neuropathy is a side-effect of some of the treatments for myeloma such as Velcade and thalidomide, and it can cause altered sensation of the feet and toes making it difficult to feel the car pedals. You could be fined up to 1,000 if you don t tell the DVLA about a condition that might affect your ability to drive safely. You could also be prosecuted if you have an accident. Once you have informed the DVLA of any condition you should get a decision about what needs to happen next within 6 weeks - it may consult your doctor and arrange for you to be examined or take a driving assessment. The DVLA will then decide whether you need a new driving licence, perhaps for a shorter period (1, 2 or 3 years), whether you need to adapt your car or whether you must stop driving and give up your licence. You can appeal any decision made. Is it ok to drink alcohol while on myeloma treatment? It is generally fine for myeloma patients to drink alcohol, but this should be in moderation and within the NHS recommended limits for the general population (no more than 14 units a week). That said, some drugs used to treat myeloma, such as thalidomide, can sometimes cause drowsiness or dizziness, so if you are affected in this way it may be best to avoid alcohol as it may make any drowsiness or dizziness worse. It may also be a good idea to avoid alcohol for some time following high-dose therapy and stem cell transplantation (HDT-SCT) as the high-dose chemotherapy used can temporarily damage the lining of the gastrointestinal tract causing irritation, pain, nausea or diarrhoea, which alcohol can make worse. Other supportive drugs used for myeloma patients, such as some of the anti-sickness medications and morphine-based pain-killers, can also cause drowsiness so you should be aware of this when drinking alcohol. Alcohol can also interact with a particular type of antibiotic called metronidazole (Flagyl ) causing some unpleasant side-effects if you are taking this medication you shouldn t drink alcohol. In general, if any of your myeloma treatment is causing nausea or diarrhoea, then it may be a good idea to avoid alcohol. Other than that, having the odd glass of wine or beer is not going to affect you whilst you are on treatment and some patients say a glass of wine with their evening meal is very enjoyable and helps them relax. If you have a question, contact our Myeloma Infoline: call , visit or AskTheNurse@myeloma.org.uk. Summer 2016 Myeloma Matters 19

20 LIVING WELL WITH MYELOMA BY VICKY KING Patient Information Officer, Myeloma UK This regular feature looks at dealing with pain; planning ahead for the end of life; and things you need to think about when going on a holiday. 20 Myeloma Matters Summer 2016

21 LIVING WELL WITH MYELOMA PLANNING AHEAD: FOR THE END OF LIFE In this article, Myeloma Matters asks Ellen Watters, one of our Myeloma Information Specialists, a series of questions about end of life and why it is important for patients and their families to plan ahead, and make decisions about their care towards the end of life. If you are wondering whether it is the right time for you to think about this and order the new Myeloma UK Planning ahead Infopack mentioned in our Newsround section, this article might help. What is meant by end of life? End of life means the patient has a few months or even a year left to live. For myeloma patients this tends to be when myeloma progresses and nothing more can be done to bring the myeloma under control. Generally this happens because: The myeloma no longer responds to treatment There are no more treatment options available The benefits of myeloma treatment are outweighed by maintaining a good quality of life The patient decides to stop myeloma treatment When should patients and carers think about end of life care? Patients and carers can plan ahead and prepare for end of life at any point following a myeloma diagnosis. For some, it might be something that patients want to think about early on and others may think about it at a later stage. For some patients it might just be rethinking their priorities after their diagnosis and deciding to spend time doing what is most important to them. Others might want to think in more detail and make plans about what they want to happen when end of life approaches, however far off that might be. Why is it important to plan ahead? The majority of enquiries we get on this topic are from patients and family members who want to plan ahead and be prepared. Planning ahead is important as it can help people affected by myeloma to take back some of the control in a situation that can feel overwhelming. I know for lots of people, thinking or talking about death can be difficult. Although it can be upsetting, try to discuss end of life care with family members by being open and honest with each other. It is important that a patient's family and healthcare professional team are aware of their wishes, e.g. if a do not resuscitate order is in place, so that these are respected. However, if this is too difficult to talk about with family members, a doctor or nurse will also be willing to discuss and answer any questions patients may have about end of life. Being prepared and planning ahead can help patients and their family to focus and make the most of all the time they have by being with the ones they love and doing things they enjoy. What happens at the end of life? I receive a lot of s and calls on the Infoline about what happens at the end of life and what to expect. It is difficult to predict exactly what will happen at the end of life, but generally most myeloma patients tend to develop an infection (e.g. pneumonia) or kidney failure. At this stage, support is put in place for end of life care, which focuses on the needs and wishes of the patient, with input from a palliative care team to ensure that the patient is comfortable and maintains as good a quality of life as possible. Summary We know that, for many people, end of life is a very difficult subject area. Myeloma UK developed our 'Planning ahead' Infopack with its primary aim being to deliver honest and open answers about the end of life. You can download the pack from our website or request a hard copy from the Myeloma Infoline on Summer 2016 Myeloma Matters 21

22 LIVING WELL WITH MYELOMA DEALING WITH PAIN This article explains the causes of pain in myeloma and how each type of pain can be treated and managed. Introduction 80% of myeloma patients report pain to their doctor or nurse at some point during their myeloma. Pain can have a detrimental impact on a patient s quality of life and interfere with their day-to-day activities. Effective control and management of pain is an important aspect of myeloma treatment; pain can be managed and even controlled entirely once the underlying cause has been identified. Causes of pain Myeloma bone disease: Myeloma bone disease is a thinning and weakening of the bones and is one of the most common causes of pain in myeloma. It can cause the bones to feel achy and be more prone to fracture. Peripheral neuropathy: Peripheral neuropathy is damage to the nerves that make up the peripheral nervous system causing pain, tingling and altered sensation. Some myeloma treatments such as thalidomide and Velcade (bortezomib) can cause peripheral neuropathy. Newer treatments such as Imnovid (pomalidomide, a newer version of thalidomide), and improvements in how treatments are given, have reduced the risk of peripheral neuropathy. Infection: Infection is very common amongst myeloma patients as their immune systems are often compromised. Pain and discomfort from infection can get worse if left untreated. Managing pain Medical treatments There are many different approaches to managing pain, some of the most common are described below. Pain-killers: Pain-killers can be used to help alleviate pain. Pain-killers come in many different forms (e.g. tablet, liquid) the form will be selected depending on the type and level of pain patients have. Over the counter analgesics, e.g. paracetamol, can be used to treat mild pain but patients with more severe pain can be prescribed opioids such as morphine and oxycodone. Certain drugs that are not normally used as pain-killers can be prescribed to help with the pain caused by peripheral neuropathy, e.g. amitriptyline, gabapentin. Bisphosphonates: Bisphosphonates are a supportive treatment used to reduce the break down of bones caused by myeloma. Reducing the bone breakdown reduces pain as the bones are less likely to become damaged and fracture. Radiotherapy: Targeted radiotherapy can be used to treat severe, localised bone pain. Radiotherapy can be used to kill the myeloma cells in a particular area, reducing pain. Surgery: Bone fractures in the spine can cause pain. Percutaneous Vertebroplasty and Balloon Kyphoplasty are two surgical options that involve injecting bone cement into the spine to reconstruct the vertebra. This surgery can often help to relieve pain caused by damage to the spine. Changes to treatment: Pain caused by peripheral neuropathy can be improved by reducing the dose of a drug, or stopping treatment with that drug (temporarily or permanently). Antibiotics: Infections can be brought under control using antibiotics. The patient should feel some pain relief when the antibiotics take effect. Non-medical strategies: Transcutaneous electrical nerve stimulator (TENS) machines are thought to encourage the brain to release endorphins - the body s natural pain reliever - by sending small electrical impulses through electrodes on the skin, improving symptoms of pain. Positioning of the body can affect the level of pain experienced. Moving into a more comfortable position when sitting down or lying in bed, using supportive pillows if necessary, can be helpful in alleviating pain. A number of complementary therapies can be useful in pain management. Acupuncture can help as it is thought to minimise activity in the areas of the brain that process pain. Gentle massage can be beneficial for pain relief by encouraging relaxation and helping with muscle tension. Patients should let their doctor or nurse know if they are planning on seeing a complementary therapist; ensure that they re seeing a qualified complementary therapist and make them aware of their myeloma. Summary Pain can have an effect both physically and emotionally for myeloma patients. Being honest about any pain the patient is feeling and letting their doctor or nurse know as soon as possible allows them to provide the most appropriate and effective treatment. For more information please visit to download our Pain and myeloma Infoguide or call our Myeloma Infoline on to speak to a Myeloma Information Specialist. 22 Myeloma Matters Summer 2016

23 LIVING WELL WITH MYELOMA GOING ON HOLIDAY: THINGS FOR PATIENTS TO THINK ABOUT Taking a holiday can offer a break from day-to-day life and provide opportunities to visit new places, new cultures and relax. Holidays don t have to stop following a myeloma diagnosis, but careful planning and a few sensible precautions are needed to ensure a safe and enjoyable holiday. We know myeloma is a very individual cancer and patients will differ in how they approach taking a holiday. This article therefore gives some general tips. Before booking a holiday Patients should chat to their doctor and tell them they are thinking about a holiday or planning a trip. This is especially important if patients are on treatment and their doctor can advise if it s safe to travel or not. Consider if any vaccinations are required - it is important to ask a doctor or nurse if any travel vaccinations are needed. Some vaccinations are live and are not recommended for myeloma patients due to their weakened immune systems. If you are prone to picking up infections, it may be worth asking your doctor about taking a course of emergency antibiotics with you. Before going on holiday Get a doctor s letter patients should take a letter from their doctor detailing all the treatments they take. Get travel insurance - it can be harder and more expensive to get travel insurance if you have myeloma, but there are some companies who specialise in travel insurance for people with cancer. Our Travel Insurance Infosheet contains a list of recommended companies. Medication take enough medication to last the whole trip and a little bit extra, in case of any unexpected delays. Take other drugs to cover any unexpected diarrhoea, constipation or increased pain. Carry any medication in hand luggage carry all medication in their original packaging with a doctor s letter detailing what they are and why they are required. Travel arrangements contact the travel or airline company if patients require additional assistance while travelling. Tips for staying safe while flying To reduce the risk of deep vein thrombosis or blood clots, patients should try to exercise their feet/ legs and wear flight stockings when on long-haul flights Keep well hydrated during the flight rather than rely on catering, take a supply of bottled water, but remember about the restrictions placed on what liquids you can take through security checks at airports Tips for staying safe while on holiday Sun safety chemotherapy and radiotherapy can make skin more sensitive to the sun, which may be a consideration if you ve recently completed a course of either. Staying in the shade, wearing a hat and applying sun cream frequently helps patients to minimise the risk of burning Food and drink abroad to minimise the risk of infection, patients should only drink bottled water, avoid ice in drinks, salad and any uncooked meat or fish Summary Going on holiday as a myeloma patient can require more careful planning than normal but this doesn t mean you should avoid it. Discussing your plans with your doctor can be reassuring and they can tell you about any travel vaccinations you may need. For more information about travelling, you can watch a patient s experience of travelling with myeloma on our Myeloma TV channel, request a copy of our Travel insurance and myeloma and Travelling with myeloma Infosheets by calling our Infoline on or visit www. myeloma.org.uk/publications Summer 2016 Myeloma Matters 23

24 PATIENT EXPERIENCE MY MYELOMA STORY NAME: David Corrin LIVES: Isle of Man AGE: 67 A lot has happened in the last 12 months and for someone who had never been in hospital in 66 years, it has been somewhat of a roller coaster ride. The story starts in late I had a routine blood test for hypertension but it also showed that I had an elevated protein level in my blood and I was referred to the local haematology consultant. Six weeks later I saw the consultant at my local hospital in the Isle of Man who told me I had MGUS (Monoclonal Gammopathy of Undetermined Significance). It meant nothing to me. The consultant gave me a leaflet on the subject and told me to study it and go back with any questions at the next appointment. In the meantime a full skeletal X-ray was organised. Once home, I read the leaflet and it mentioned cancer and myeloma which didn t sound good to me. However, with the consultant s words ringing in my ears to the effect that there was only a 1 in 20 chance of MGUS developing into myeloma I filed it to the back of my mind. A pattern of quarterly appointments developed. The skeletal X-ray revealed no problems and apart from the elevated protein level of 20/21 all the other blood parameters were good. Fast forward to December Whilst lifting a suitcase on holiday I felt a muscle twinge in my groin. By January 2015 it wasn t getting better. I was sent for physio, but it made no improvement and things felt like they were getting worse. I was now walking with a noticeable limp and it had become almost impossible to lie on my right side. At the start of April I went to my hospital appointment and was told my paraprotein level had risen to 28 and the doctor ran through a list of possible symptoms. I mentioned the pain I had been experiencing and he sent me for an X-ray. Shortly after we went to Italy for 10 days for a well earned holiday. It was a fantastic break but I was still limping and was finding some movements quite uncomfortable. On our return I went to see my GP. She looked up the X-ray results and they revealed no abnormality. I explained about the physio having no effect and she arranged a pelvic X-ray. It showed a significant lesion on the Iliac bone in my pelvis and an urgent referral was made to an orthopaedic consultant. I think this was the defining moment, the red button was well and truly pressed. We had gone to Defcon 1. When I met the orthopaedic consultant he said he suspected that it might be bone cancer and the limping was caused by the lesion being close to a mass of nerves. He arranged CT and MRI scans to be done. The results of the scans detected two lesions, the one on the pelvis and one on the left femur. He sent my file to Oswestry Orthopaedic Centre of Excellence to be reviewed by a multidisciplinary team. Within days I was told it was likely to be myeloma. In the meantime I found the Myeloma UK website and read up on myeloma. When I met the haematology consultant, he said my paraprotein level had risen to 34 and agreed it was likely to be myeloma. I was told that the local multidisciplinary team would discuss my case. I received a call later that day to say I was being referred to a myeloma specialist at the Royal Liverpool Hospital. At the Royal Liverpool Hospital I had blood tests and met with the haematology consultant. He thought it was myeloma, but couldn t make a definitive diagnosis until they had run further tests. Two weeks later I was admitted as an inpatient for a week. At that point the real seriousness of my position was brought home as we were about to have a week s break in Cornwall. My consultant wasn t happy with my calcium level and told us to be no more than an hour s travel of Truro Hospital in case there were any problems. That really does focus your mind! In the event it all went very smoothly. Back from holiday and I checked into the Royal Liverpool Hospital. I had blood tests and they also did a bone marrow biopsy. The procedure went ahead smoothly and was only mildly uncomfortable for a very short period. Myeloma was confirmed. The large lesion on the pelvis was not deemed a risk as it should respond to treatment, and the lesion on the femur was only 10cm so did not represent a risk of fracture. I was invited to join the Myeloma XI clinical trial and after considerable thought, decided to accept. I was randomly chosen for the most intensive arm of the trial which involved 6 to 8 cycles of 28 days 24 Myeloma Matters Summer 2016

25 PATIENT EXPERIENCE Summer 2016 Myeloma Matters 25

26 PATIENT EXPERIENCE each. There were four drugs involved but the principal one was Kyprolis (carfilzomib) which had to be administered intravenously in hospital over two days, for three weeks out of every four. Living on the Isle of Man meant that I had to travel to the Royal Liverpool Hospital, which meant significant travelling each week and being away from home for three nights all pretty exhausting. I was given a dental examination before starting treatment, as part of the ongoing support involves a monthly infusion of a bone strengthening drug which can impact on your jaw bone. The check-up anticipates if any major dental work would be required in the next two years. I emerged minus two teeth. I then checked into the Royal Liverpool Hospital for what I thought was a two day stay to start my treatment this turned into 12 days as they adjusted my support treatments to get the optimum response. After that a pattern soon formed. We would leave home late Monday afternoon, fly to Liverpool and check into our hotel. Tuesday and Wednesday were blood tests and infusions and we d fly home late Wednesday evening. The treatment went well and I had no significant reaction. The most glitches arose from the supportive drugs. My body temperature spiked a couple of times. I also had a severe rash due to an allergic reaction to allopurinol and co-trimoxazole, but suitable substitutes were found. After one month of treatment my paraprotein level dropped from 35 to 6 which was fantastic and the serum free light chain went from 1,600 to the normal level of 6. They ran the tests three times as they couldn t believe how good the results were. By the end of the second cycle the paraprotein level was nil and this was confirmed at the end of the third cycle. The decision was made to stop the treatment at the end of the 4th cycle. The pressure was now off the nerves in my right leg and by the end of the third cycle the limp had gone and I could lie on my right side without discomfort. At the clinic appointment in December, the next stage of treatment was discussed, and it was clear that high-dose therapy and a stem cell transplant (HDT-SCT) was the preferred route and had the potential to lengthen the remission period significantly. Before the HDT-SCT, an X-ray of my pelvis revealed the lesion on my femur had grown to 30cm. However, a PET scan showed the site wasn t active and didn t represent a fracture risk. Mid January 2016 saw me receive a single dose of chemotherapy, cyclophosphamide, followed by a daily injection of growth hormone to stimulate the maximum production of stem cells for harvesting. The last week in January saw us in Liverpool for the week and I found it quite gruelling. The stem cell harvesting took three days, for six hours per day connected to the apheresis machine which produced sufficient stem cells which went off to be deep frozen. On 19 February we were back at the stem cell clinic and signing the consent forms after having a full MoT on heart and lungs. On 4 April I was admitted to start the treatment. On the Monday a PICC line was fitted. The high-dose therapy, melphalan, was administered on Tuesday. Then the following day the stem cells were returned. When they sit down with you and run through the risks and side-effects from the stem cell transplant process it takes a while to really understand that it isn t a menu of complications from which to choose. You may experience some or all of them, but you won t escape entirely. For several days I had no loss of appetite, no loss of taste, no sickness. Even my hair remained reassuringly intact and the blood results were all within the correct parameters. Things are measured in days and they use Day zero as the day that you receive your stem cells back again. On day 5 my throat became very sore and diarrhoea developed. I had set myself an objective from the beginning to try and maintain good levels of fluid intake and eat a balanced amount of food each day. With the use of the various mouth washes that the team provided I was able to sustain this objective. There were days when my attempt at eating faltered, but luckily my taste for chocolate never diminished! It is important to keep the team advised of anything which you feel is out of kilter. My first issue was a temperature spike to 37.9 degrees. However the doctors and nurses responded quickly. I was also found to be sensitive to IV antibiotics which induced an interesting red rash, but it was quickly brought under control. During the whole process I generally felt OK, probably more familiar with the toilet than usual, but otherwise better than I expected to feel. The regular contact from the nursing team was very reassuring and the care and compassion combined with their professionalism and good humour provided an environment that was as comfortable and encouraging as possible. My white blood cell count dropped to the predicted 0.1, ground zero as it were! However, within a few days it was 3.5 and in the normal range. The sore throat went and the other side-effects diminished. Slowly some of the support treatment was withdrawn and I was allowed to make excursions off the ward, but the first one quickly made me realise just what a hammering my stamina had taken. By now my hair had disappeared, but strangely some ladies thought the overall effect suited me. Returning home three weeks after my admission was interesting as I had to fly, and needed assistance as I couldn t walk the long distances at the airport. There will now be a long period of recuperation before I fully recovered and in the short-term I will be very vulnerable to infection but gradually things will improve. The support from my family and friends has been amazing and essential to carrying me through the difficult times but, the support of my wife has made the journey immeasurably easier than it might have been. Four weeks after leaving hospital and making excellent progress, I was discharged by the stem cell team and returned to the care of the myeloma consultant. 26 Myeloma Matters Summer 2016

27 FUNDRAISING ASK THE NURSE NEWS 125 Myeloma UK supporters, including patients and their family and friends, doctors and nurses cycled 500km over four days to raise money for myeloma research. INAUGURAL LONDON PARIS RIDE A HUGE SUCCESS, PLANS TO MAKE 2017 RIDE EVEN BIGGER On the 5-9 May, 125 riders, including myeloma patients and their family and friends, doctors and nurses, as well as teams from our pharmaceutical and diagnostic partners Abingdon Health, Amgen, Celgene and Takeda Oncology, cycled 500km over four days in our inaugural London Paris Ride to raise funds for myeloma research. Riders enjoyed a rare and privileged finale of entering Paris as one huge peloton, under police escort, cycling past the Arc de Triomphe and then on to the finish near the Eiffel Tower. Funds are still coming in, but so far participants have raised over 300,000. Myeloma UK Chief Executive Eric Low said, Congratulations to all of our participants, and a huge thank you for raising so much money. Myeloma is a relapsing and remitting cancer and research is vital so that we can better understand why myeloma develops, how it progresses and why treatments stop working. Plans are already underway to make the 2017 ride even bigger. The 2017 ride is set to take place on May The ride is a pro-ride experience that caters to all cyclists, from committed novices up to elites. With three different speed groups and experienced Ride Captains who figuratively and literally push you on, anyone who s willing to put in some training can take on this challenge. The ride features rolling road closures, motorcycle outriders, mechanical backup and sports physios to ensure all riders, no matter their level of ability, get to experience riding like a pro. In the words of one of our 2016 riders, To those who feel they could not do something like this, there s lots of time to start training now. This was the single greatest experience of my adult life because of the sense of achievement I felt and the comradery I experienced throughout the ride. To see what it was like to be part of our London Paris ride check out our videos and photos from You can also register for next year s event at our dedicated ride website Thank you to our generous sponsors who supported the 2016 inaugural ride: Summer 2016 Myeloma Matters 27