Management of Multiple Myeloma: The Changing Paradigm

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1 Management of Multiple Myeloma: The Changing Paradigm Myeloma 101: Disease Overview Craig Emmitt Cole, MD University of Michigan Comprehensive Cancer Center

2 What are Blood Cancers, What IS Multiple Myeloma? Red Blood Cells Anatomy and Bone Marrow Biology Stem Cell (just a little.) White Blood Cells Bone Marrow Blood Factory Platelet Cells Lymph Glands Lymph Cells Antibody Proteins Plasma Cells

3 Red Blood Cells Bone Marrow LEUKEMIA Stem Cell White Blood Cells Bone Marrow Blood Factory Platelet Cells Lymph Glands Lymph Cells LYMPHOMA Antibody Anatomy Free Light Chains Monoclonal Antibody M-proteins Proteins Plasma Cells MULTIPLE MYELOMA Light chains Heavy chains

4 Multiple Myeloma Today CML, chronic myeloid leukemia; CLL, chronic lymphocytic leukemia; MM, multiple myeloma; NHL, non-hodgkin lymphoma. Leukemia & Lymphoma Society. Facts Available at: Accessed April 6, Siegel RL et al. CA Cancer J Clin. 2016;66:7.

5 Multiple Myeloma and Common Symptoms Low Blood Counts Anemia is present in 60% at diagnosis May lead to anemia and infection Decreased Kidney Function Occurs in over half of myeloma patients Bone Damage Affects 85% of patients Leads to fractures Bone Turnover Leads to high levels of calcium in blood (hypercalcemia) Weakness Fatigue Infection Weakness Bone pain Loss of appetite Weight loss About 10% to 20% of patients with newly diagnosed myeloma will not have any symptoms. Multiple Myeloma Complications. Accessed April 14, Campbell K. Nurs Times. 2014;110:12.

6 Key Steps to Take on Your Journey Laboratory tests and diagnosis Staging and prognosis Obtain a second opinion Treatment The promise of precision medicine

7 Diagnosing Myeloma: Learn Your Labs! Blood and Urine Tests CBC Number of red blood cells, white blood cells, and platelets CoMP Measure levels of albumin, calcium, lactate dehydrogenase [LDH], blood urea nitrogen [BUN], and creatinine. Assess function of kidney, liver, and bone status and the extent of disease. Beta2 MicroG Determine the level of a protein that indicates the presence/extent of MM and kidney function SPEP Detect the presence and level of M protein IFE Identify the type of abnormal antibody proteins: IgG, IgA, κ,or λ SFLC Freelite test measures free light chains (kappa or lambda) in blood 24-hr Urine Analysis UPEP Detect Bence-Jones proteins (otherwise known as myeloma light chains) in Urine Determine the presence and levels of M protein and Bence Jones protein in the Urine CBC, complete blood count; CMP, complete metabolic panel; B2M; beta-2 microglobulin; SPEP, serum protein electrophoresis; IFE, immunofixation electrophoresis; SFLC, serum free light chain assay; UPEP, urine protein electropheresis;

8 Q: Where Do We Start Looking for Myeloma? A: Monoclonal Protein!

9 Albumin Serum Protein Electrophoresis Normal Antibodies α Zone Proteins β Zone Proteins γ Zone Proteins Lightest Plasma Heaviest IgG IgA IgM Plasma Cells

10 Albumin Serum Protein Electrophoresis Monoclonal Gammopathy α Zone Proteins Treatment β Zone Proteins Monoclonal protein γ Zone Proteins Lightest Plasma Heaviest IgG Kappa M-Protein IgG Kappa M-Protein Monoclonal Plasma Cells

11 Albumin Serum Protein Electrophoresis Monoclonal Gammopathy Light Chains α Zone Proteins β Zone Proteins Monoclonal Light Chain Monoclonal protein protein γ Zone Proteins Lightest Plasma Heaviest Monoclonal Plasma Cells

12 Light Chain Monoclonal Gammopathy Detection: Serum Free Light Chains In 17% of patients with myeloma only produce a light chains. Serum free light chains (FLC) blood test uses κ and λ antibodies against specific areas that are exposed on FLCs. FLCs independently quantify the two light chain types. Clonality can be identified by the demonstration of an abnormal ratio of κ : λ FLCs. κ light-chain-only multiple myeloma Normal Range λ light-chain-only multiple myeloma Hutchison, C. A. et al. (2009) Serum free light chain assessment in monoclonal gammopathy and kidney disease Nat. Rev. Nephrol. doi: /nrneph

13 Light Chain Monoclonal Gammopathy Normal Normal with inflammation 1.00mg/dL 1.80mg/dL Kappa Lt. Kappa Chain Lt. Chain Lambda Lambda Lt. Chain Lt. Chain 1.70mg/dL 1.00mg/dL Ratio:

14 Light Chain Monoclonal Gammopathy mg/dL Kappa Lt. Chain MM Kappa Lt. Chain Lambda Lt. Chain Normal with inflammation 0.50mg/dL Ratio: 1.06 Ratio: >100 Positive Kappa Monoclonal Serum Light Chains

15 Light Chain Monoclonal Gammopathy After therapy of MM Restore normal Light Chains 1.00mg/dL Kappa Lt. Chain 1.00mg/dL Kappa Lt. Chain Lambda Lt. Chain Ratio:100

16 Diagnosing Myeloma: Know Your Imaging Tests! Assess changes in the bone structure and determine the number and size of tumors in the bone X-ray MRI CT scan PET scan Conventional x-rays reveal punched-out lytic lesions, osteoporosis, or fractures in 75% of patients. MRI & PET/CT appear to be more sensitive (85%) than skeletal x-rays for the detection of small lytic bone lesions.

17 Diagnosing Myeloma: Know Your Bone Marrow Tests! Bone Marrow Aspiration and Biopsy Jamshidi needle Bone marrow Hip bone Skin Cytogenetic Analysis Karyotyping Chromosome FISH (fluorescence in situ hybridization) MM cell

18 What s inside those Myeloma Cells: FISH (fluorescence in situ hybridization) Chromosome 7

19 Serum levels of 2 Microglobulin are of Prognostic Importance in Myeloma 2 Microglobulin The higher the 2 Microglobulin = the more plasma cells and/or the worse the kidney function.

20 Putting the Results Together Imaging results Blood and urine test results Bone marrow analysis Staging and Prognosis

21 Multiple Myeloma Staging β2 Microglobulin B2M B2M <3.5 mg/dl B2M >5.5 Albumin 3.5 g/dl Neither stage I nor stage III Stage I Stage II Stage III Greipp PR et al. J Clin Oncol. 2005;23:3412.

22 How Aggressive Is My Myeloma? Risk Level* (Degree of Aggressiveness) 80 High Risk Intermediate Risk Standard Risk Patients affected (%) FISH del 17p t(14;16) t(14;20) GEP High-risk signature FISH t(4;14)* Cytogenetic del 13 or hypodiploid PCLI 3% All others including: Hyperdiploid t(11;14) t(6;14) Survival (years) *Based on the Updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (msmart) Consensus Guidelines 2013 Mikhael JR et al. Mayo Clin Proc. 2013;88:360.

23 Revised International Staging System for Multiple Myeloma Prognostic Factor Stage I Stage II Stage III ISS Stage I -Serum β2-microglobulin <3.5 mg/l, serum albumin >3.5 g/dl II- Not ISS stage I or III III- Serum 2-microglobulin >5.5 mg/l ISS Stage I ISS Stage II ISS Stage III AND/OR AND AND LDH Normal Serum LDH: <the upper limit of normal High Serum LDH: > the upper limit of normal Cytogenetic* High Risk: del(17p) t(4;14) t(14;16) Standard risk No high-risk CA Normal High AND/OR AND AND/OR No high Risk Not R-ISS Stage I or III High Risk *Based on the Updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (msmart) Consensus Guidelines 2013 Mikhael JR et al. Mayo Clin Proc. 2013;88:360. Palumbo et al. JCO. September 10, 2015 vol. 33 no

24 The Promise of Precision Medicine Starts With Genomics

25 How Do We Match the Right Myeloma Medicines to Each Patient? Precision Medicine Personalizing medical care with DNA testing of many different genes (genomics) at the same time Bone marrow tissue samples Newly diagnosed relapse Genomic testing Chromosome Tailored treatment MM cell DNA Gene expression profiling [GEP] Whole-genome/ whole-exome sequencing) Next-generation sequencing

26 MMRF CoMMpass SM Study: Advancing Personalized Medicine Research Landmark study focusing on the genomics of myeloma Goals: Learn which patients respond best to which therapies Achieve better treatments targeted to each patient s biological makeup 1,000 newly diagnosed patients will be followed for at least 10 years Enrollment complete! For more information call the MMRF at or visit

27 Know Your Myeloma Genomics Tissue banking (NDMM to RRMM) What tests are available? Is it available to me? Interpreting results

28 The Typical Course of Myeloma Disease Burden (M-Protein) Asymptomatic No anemia or bone lesions. Normal calcium levels and kidney function. MGUS or Smoldering Myeloma Symptomatic Possible anemia, bone lesions, high calcium levels, or reduced kidney function. Auto Transplant Novel Therapies Active Maintenance Therapy Relapse myeloma Plateau Remission Up Front Therapy Time Salvage Therapy Brief Plateau Refractory Relapse Relapse Progressive Myeloma Refractory Therapy Myeloma is not responsive to therapy.

29 After Establishing a MM Diagnosis, Find Out From Your Doctor... Treatment What is your response to therapy? IgG Kappa M-Protein IgG Kappa M-Protein

30 Treatment Overview

31 Overview of Treatment Approach MGUS Smoldering MM Active myeloma Close monitoring (observation) Close monitoring (observation) If high risk: possible myeloma drugs? Initial therapy Myeloma drugs High-dose chemotherapy/ stem cell transplantation (option, if possible) Maintenance option Therapies for relapsed/ refractory myeloma If bone loss: bisphosphonates Bone loss: bisphosphonates + other supportive treatments Clinical trial participation should be considered.

32 Currently Available Therapies Targeting Myeloma Cells in the Bone Marrow Microenvironment T NK M Antibodies to cell surface targets: Daratumumab Elotuzumab Isatuximab Cytokines, growth factors IL-6, VEGF IGF-1, SDF-1 BAFF, APRIL, BSF-3 Bone marrow stromal cell Cytokines BAFF-R IGF1R CD138 CD38 VEGFR NF- B FGFR3 CS1 TNF TGF VEGF Smad, ERK NF- B CD40 C56 PKC PI3-K JAK/STAT3 Raf NF- B Migration Akt MEK/ERK Adhesion molecules Bcl-xL Mcl-1 Bcl-xL IAP Cyclin-D MEK/ERK p27 Kip1 GSK-3 FKHR Caspase-9 NF- B mtor Bad MM cell Survival Anti-apoptosis Proliferation Survival Anti-apoptosis Cell cycle Proliferation Anti-apoptosis Adhesion Survival Anti-apoptosis Cell cycle Targeting MM cell Targeting MM cell and BM microenvironment Proteasome inhibitors: Velcade, Kyprolis, Ixazomib IMiDs: Thalomid, Revlimid, Pomalyst HDAC inhibitor: Farydak, Ricolinostat NF-B Hideshima T, Anderson KC. Nature Rev Cancer. 2002;2:927. Hideshima T et al. Blood. 2004;104:607. Hideshima T, Anderson KC. Nat Rev Cancer. 2007;7:585. ICAM-1 LFA-1, MUC-1 VCAM-1, fibronectin VLA-4

33 Evolution of Multiple Myeloma Treatment: 10 New Drugs Approved in 12 Years Conventional Therapy Novel Therapy High-dose chemotherapy with autologous bone marrow transplant High-dose chemotherapy with autologous stem cell support Revlimid Kyprolis Ninlaro VAD Thalomid Pomalyst Velcade Doxil Farydak High-dose melphalan High-dose dexamethasone Empliciti Darzalex Melphalan and prednisone Bisphosphonates Chemotherapy IMiD HDAC inhibitor Monoclonal Antibody Steroid Proteasome inhibitor Transplant Bone support VAD, vincristine, doxorubicin, dexamethasone; IMiD, immunomodulatory drug; HDAC, histone deacetylase.

34 Continuing Evolution of Multiple Myeloma Treatment: New Classes and Targets Novel Therapies and Immunotherapy Atezolizumab* Revlimid Thalomid Kyprolis Pomalyst Ninlaro Empliciti Pembrolizumab Nivolumab Filanesib* Vaccines* CAR-T* Velcade Doxil Farydak Isatuximab* Oprozomib* Darzalex Selinexor* IMiD HDAC inhibitor Monoclonal Antibody Vaccines SINE Proteasome inhibitor Chemotherapy Adoptive T cell therapy Checkpoint inhibitors KSP inhibitor PLD, peglylated liposomal doxorubicin; IMiD, immunomodulatory drug; HDAC, histone deacetylase; KSP, kinesin spindle protein, SINE, selective inhibitor of nuclear export *Not yet FDA-approved; only available in clinical trials Treatments studied in MMRC trials FDA-approved for a non-mm indication

35 Third/ Fourthgeneration agents Novel classes of Therapy Selected Novel Drugs Being Explored in Clinic Trials Proteasome inhibitors IMIDs Monoclonal antibodies Check Point Inhibitors BTKi HDAC inhibitors Pleiotropic Pathway Modifier Kinesin Spindle Inh CDK marizomib, oprozomib, ixazomib CC-220 anti-cd38, anti CD-138 conjugate, anti- BCMA conjugate, antics1-conjugate Durvalumab, Atezolizumab, Pembrolizumab Nivolumab Ibrutinib, AVL-292 panobinostat,* romidepsin, ricolinostat CC:122 ARRY PD , SCH727965, AT7519 BCL antagonist HSP90 SINE XPO antagonist FGFR3 17p mutated ABT263 Ganetespib (STA-9090) KPT-330 (Selinexor) TKI258, MFGR1877S Idasanutlin

36 Clinical Trials

37 Advancements in Survival from Multiple Myeloma 95,874 With new biology based medications response rates for newly diagnosed myeloma are now 91 to 98%. New myeloma cases among men and women ages 40 to 79 years will increase by 28% (from 16,000-21,000) by From 2011 to 2022, expect the number of patients living with myeloma to increase by 55% (from 76, ,000), due to improvements in prognosis. Blood (ASH Annual Meeting Abstracts) : Abstract 2948; AACR Annual Meeting, April 20, 2016; New Orleans, LA.; Abstract ,814 19,851 More 54,963People Have Survived 2015 People in the United States living with, or in a remission from Multiple Myeloma

38 Summary Multiple myeloma can have numerous effects on the body Genomics is growing and may lead to personalized treatments Survival improving because of new drugs and new combinations of drugs Treatment paradigm will continue to change with the approval of additional novel agents Be an informed and empowered patient!

39 MMRF Resources Multiple Myeloma Disease Overview brochure Multiple Myeloma Treatment Overview brochure MMRF CoMMunity Gateway

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