Change Summary - Form 2116 (R3) 1 of 6

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Transcription:

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 2116 1 Was the recipient transplanted for or do they have a history of amyloidosis? New Question 2116 2 Did the recipient have features of multiple myeloma? New Question 2116 3 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) 1 2116 4 New Question Specify the date the best response first 2116 5 Date assessed: Question Text Change Question text changed Date assessed: began: 2 2116 sample source unknown: Removed 7 2116 sample source unknown - value Removed 8 2116 10 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): 9 2116 12 Serum immunofixation Option value change option value changed 11 2116 13 /positive /negative 12 2116 15 bands: Question Text Change Question text changed bands: New monoclonal bands 14 2116 16 Total urinary protein excretion: New Question 2116 17 Total urinary protein excretion value New Question

Change Summary - Form 2116 (R3) 2 of 6 2116 18 Urinary monoclonal protein (Mspike): Question Text Change Question text changed Urinary monoclonal protein (M-spike): Urinary monoclonal light chains: 15 2116 20 Urinary immunofixation Option value change option value changed 17 2116 21 /positive /negative 18 2116 23 bands: Question Text Change Question text changed bands: New monoclonal bands 20 2116 24 Serum free light chains κ (kappa): Option value change option value changed Not known 21 2116 27 Serum free light chains λ (lambda): Option value change option value changed Not known 24 2116 30 Was the disease status assessed by cytogenetic testing (conventional or FISH)? New Question 2116 31 FISH? New Question 2116 32 Date assessed: New Question 2116 33 conventional cytogenetics? New Question 2116 34 Date assessed: New Question 2116 35 Specify the recipient s best hematologic response to the HCT: New Question 2116 36 Date assessed: New Question 2116 37 Specify date New Question 2116 38 Specify the recipient s best cardiac response to the HCT: New Question 2116 39 Date assessed: New Question 2116 40 Specify date New Question 2116 41 Was there clinical improvement in GI involvement in response to the HCT? New Question 2116 42 Date assessed: New Question 2116 43 Specify date New Question 2116 44 Specify the recipient s best hepatic response to the HCT: New Question 2116 45 Date assessed: New Question 2116 46 Specify date New Question 2116 47 Specify the best response of autonomic neuropathy to the HCT: New Question 2116 48 Date assessed: New Question 2116 49 Specify date New Question

Change Summary - Form 2116 (R3) 3 of 6 2116 50 Specify the best response of peripheral neuropathy to the HCT: New Question 2116 51 Date assessed: New Question 2116 52 Specify date New Question 2116 53 Specify the recipient s best renal response to the HCT: New Question 2116 54 Date assessed: New Question 2116 55 Specify date New Question 2116 56 Did any other system respond to the HCT? New Question 2116 57 Specify other system: New Question 2116 58 Specify best response to HCT for this system: New Question 2116 59 Date assessed: New Question 2116 60 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.) 27 2116 61 2116 63 Date therapy started: New Question 2116 64 Date started: Question Text Change Question text changed Date started: Date therapy started: 29 2116 65 Date therapy stopped: New Question 2116 66 Date stopped: Question Text Change Question text changed Date stopped: Date stopped: 30 2116 67 Number of cycles New Question The Number of cycles "/" checkbox was replaced with a / question 2116 70 Carfilzomib New Question 2116 84 MLN9708 New Question 2116 90 Specify other systemic therapy: Question Text Change Question text changed Specify other systemic therapy: Specify other therapy: 51 2116 92 Date therapy started: New Question 2116 93 Date started: Question Text Change Question text changed Date started: Date therapy started: 53 2116 94 Date therapy stopped: New Question 2116 95 Date stopped: Question Text Change Question text changed Date stopped: Date therapy stopped: 54 2116 96 Best response to line of therapy: Option value change option value changed Near complete remission (ncr) (Amyloidosis with no evidence of myeloma) 55

Change Summary - Form 2116 (R3) 4 of 6 2116 98 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? 57 2116 101 Date of relapse/progression: Question Text Change Question text changed Date of relapse/progression: Specify the date of disease relapse or progression: 58 2116 sample source unknown: Removed 65 2116 sample source unknown - value Removed 66 2116 106 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): 67 2116 108 Serum immunofixation Option value change option value changed 69 2116 109 /positive /negative 70 2116 111 bands: Question Text Change Question text changed bands: New monoclonal bands 72 2116 112 Total urinary protein excretion: New Question 2116 113 Total urinary protein excretion value New Question Urinary monoclonal protein (Mspike): 2116 114 Question Text Change Question text changed Urinary monoclonal protein (M-spike): Urinary monoclonal light chains: 73 2116 116 Urinary immunofixation Option value change option value changed 75 2116 117 /positive /negative 76 2116 119 bands: Question Text Change Question text changed bands: New monoclonal bands 78 2116 120 Serum free light chains κ (kappa): Option value change option value changed Not known 79 2116 123 Serum free light chains λ (lambda): Option value change option value changed Not known 82 2116 126 Was the disease status assessed by cytogenetic testing (conventional or FISH)? New Question 2116 127 FISH? New Question 2116 128 Date assessed: New Question 2116 129 Was disease detected? New Question 2116 130 Was the status considered a disease relapse or progression? New Question 2116 131 conventional cytogenetics? New Question 2116 132 Date assessed: New Question 2116 133 Was disease detected? New Question

Change Summary - Form 2116 (R3) 5 of 6 2116 134 Was the status considered a disease relapse or progression? New Question 2116 135 What is the disease status? Question Text Change Question text changed What is the disease status? What is the current disease status? 85 2116 135 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 85 2116 136 Date assessed: Question Text Change Question text changed Date assessed: Date the current disease status was established in this reporting period: 86 2116 137 Specify the recipient s current hematologic status: New Question 2116 138 Date assessed: New Question 2116 139 Specify date New Question 2116 140 Specify the recipient s current cardiac status: New Question 2116 141 Date assessed: New Question 2116 142 Specify date New Question 2116 143 Was there clinical improvement in GI involvement since the date of the last report? New Question 2116 144 Date assessed: New Question 2116 145 Specify date New Question 2116 146 Specify the recipient s current hepatic status: New Question 2116 147 Date assessed: New Question 2116 148 Specify date New Question 2116 149 Specify the current status of autonomic neuropathy: New Question 2116 150 Date assessed: New Question 2116 151 Specify date New Question 2116 152 Specify the current status of peripheral neuropathy: New Question 2116 153 Date assessed: New Question 2116 154 Specify date New Question 2116 155 Specify the recipient s current renal status: New Question 2116 156 Date assessed: New Question 2116 157 Specify date New Question 2116 158 Was any other system assessed for current status? New Question 2116 159 Specify other system: New Question

Change Summary - Form 2116 (R3) 6 of 6 2116 160 Specify the current status of this system: New Question 2116 161 Date assessed: New Question 2116 162 Specify date New Question 2116 Signature section Date New Question