Change Summary - Form 2116 (R3) 1 of 6

Transcription

1 Change Summary - Form 2116 (R3) 1 of 6 Form Question Number (r3) Question Text Change Type Description New Text Previous Text Previous Question Number (r2) 2116 Today's date: Removed "Today's date:" was removed from key fields 2116 HCT type Option value change "Syngeneic (identical twin)" was removed Bone marrow 2116 Product type Option value change option value changed PBSC Single cord blood unit Multiple cord blood units Other product Marrow PBSC Cord blood Other product Was the recipient transplanted for or do they have a history of amyloidosis? New Question Did the recipient have features of multiple myeloma? New Question Compared to the disease status prior to the preparative regimen, what was the best response to HCT since the date of the last report? Option value change option value changed Was the date of best response previously reported? The "Previously reported" checkbox was replaced with a Yes/No question Near complete remission (ncr) Relapse from CR (Rel) (untreated) Relapse from CR (Rel) (untreated) New Question Specify the date the best response first Date assessed: Question Text Change Question text changed Date assessed: began: sample source unknown: Removed sample source unknown - value Removed Serum monoclonal protein (Mspike): (only from electrophoresis): Question Text Change Question text changed Serum monoclonal protein (M-spike): (only from electrophoresis): Serum monoclonal Ig: (only from electrophoresis): Serum immunofixation Option value change option value changed /positive /negative bands: Question Text Change Question text changed bands: New monoclonal bands Total urinary protein excretion: New Question Total urinary protein excretion value New Question

2 Change Summary - Form 2116 (R3) 2 of Urinary monoclonal protein (Mspike): Question Text Change Question text changed Urinary monoclonal protein (M-spike): Urinary monoclonal light chains: Urinary immunofixation Option value change option value changed /positive /negative bands: Question Text Change Question text changed bands: New monoclonal bands Serum free light chains κ (kappa): Option value change option value changed Not known Serum free light chains λ (lambda): Option value change option value changed Not known Was the disease status assessed by cytogenetic testing (conventional or FISH)? New Question FISH? New Question Date assessed: New Question conventional cytogenetics? New Question Date assessed: New Question Specify the recipient s best hematologic response to the HCT: New Question Date assessed: New Question Specify date New Question Specify the recipient s best cardiac response to the HCT: New Question Date assessed: New Question Specify date New Question Was there clinical improvement in GI involvement in response to the HCT? New Question Date assessed: New Question Specify date New Question Specify the recipient s best hepatic response to the HCT: New Question Date assessed: New Question Specify date New Question Specify the best response of autonomic neuropathy to the HCT: New Question Date assessed: New Question Specify date New Question

3 Change Summary - Form 2116 (R3) 3 of Specify the best response of peripheral neuropathy to the HCT: New Question Date assessed: New Question Specify date New Question Specify the recipient s best renal response to the HCT: New Question Date assessed: New Question Specify date New Question Did any other system respond to the HCT? New Question Specify other system: New Question Specify best response to HCT for this system: New Question Date assessed: New Question Specify date New Question Was therapy given since the date of the last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Question Text Change Question text changed Was therapy given since the date of the last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Was planned treatment per protocol given since the date of last report? (Include any maintenance therapy, but exclude any treatment for relapse or progressive disease.) Date therapy started: New Question Date started: Question Text Change Question text changed Date started: Date therapy started: Date therapy stopped: New Question Date stopped: Question Text Change Question text changed Date stopped: Date stopped: Number of cycles New Question The Number of cycles "/" checkbox was replaced with a / question Carfilzomib New Question MLN9708 New Question Specify other systemic therapy: Question Text Change Question text changed Specify other systemic therapy: Specify other therapy: Date therapy started: New Question Date started: Question Text Change Question text changed Date started: Date therapy started: Date therapy stopped: New Question Date stopped: Question Text Change Question text changed Date stopped: Date therapy stopped: Best response to line of therapy: Option value change option value changed Near complete remission (ncr) (Amyloidosis with no evidence of myeloma) 55

4 Change Summary - Form 2116 (R3) 4 of Did disease relapse/progress following this line of therapy? Question Text Change Question text changed Did disease relapse/progress following this line of therapy? Did patient relapse/progress following this line of therapy? Date of relapse/progression: Question Text Change Question text changed Date of relapse/progression: Specify the date of disease relapse or progression: sample source unknown: Removed sample source unknown - value Removed Serum monoclonal protein (Mspike): (only from electrophoresis): Question Text Change Question text changed Serum monoclonal protein (M-spike): (only from electrophoresis): Serum monoclonal Ig: (only from electrophoresis): Serum immunofixation Option value change option value changed /positive /negative bands: Question Text Change Question text changed bands: New monoclonal bands Total urinary protein excretion: New Question Total urinary protein excretion value New Question Urinary monoclonal protein (Mspike): Question Text Change Question text changed Urinary monoclonal protein (M-spike): Urinary monoclonal light chains: Urinary immunofixation Option value change option value changed /positive /negative bands: Question Text Change Question text changed bands: New monoclonal bands Serum free light chains κ (kappa): Option value change option value changed Not known Serum free light chains λ (lambda): Option value change option value changed Not known Was the disease status assessed by cytogenetic testing (conventional or FISH)? New Question FISH? New Question Date assessed: New Question Was disease detected? New Question Was the status considered a disease relapse or progression? New Question conventional cytogenetics? New Question Date assessed: New Question Was disease detected? New Question

5 Change Summary - Form 2116 (R3) 5 of Was the status considered a disease relapse or progression? New Question What is the disease status? Question Text Change Question text changed What is the disease status? What is the current disease status? What is the disease status? Option value change option value changed Near complete remission (ncr) Relapse from CR (Rel) (untreated) (Amyloidosis with no evidence of myeloma) Complete remission Not in complete remission Date assessed: Question Text Change Question text changed Date assessed: Date the current disease status was established in this reporting period: Specify the recipient s current hematologic status: New Question Date assessed: New Question Specify date New Question Specify the recipient s current cardiac status: New Question Date assessed: New Question Specify date New Question Was there clinical improvement in GI involvement since the date of the last report? New Question Date assessed: New Question Specify date New Question Specify the recipient s current hepatic status: New Question Date assessed: New Question Specify date New Question Specify the current status of autonomic neuropathy: New Question Date assessed: New Question Specify date New Question Specify the current status of peripheral neuropathy: New Question Date assessed: New Question Specify date New Question Specify the recipient s current renal status: New Question Date assessed: New Question Specify date New Question Was any other system assessed for current status? New Question Specify other system: New Question

6 Change Summary - Form 2116 (R3) 6 of Specify the current status of this system: New Question Date assessed: New Question Specify date New Question 2116 Signature section Date New Question