Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Overall response rate (ORR) |
ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator. |
6 months after the Last Participant In (LPI) i.e., approximately 32 months |
|
| Secondary |
Number of participants with infusion reactions (IRs) |
|
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months |
|
| Secondary |
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable) |
|
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months |
|
| Secondary |
Number of participants with injection site reactions (ISRs) |
|
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months |
|
| Secondary |
CR or better |
CR or better assessed according to International Myeloma Working Group (IMWG) criteria assessed by investigator. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, and a normal FLC ratio of 0.26-1.65 is required for FLC disease only. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed. |
12 months after the Last Participant In (LPI) i.e., approximately 38 months |
|
| Secondary |
VGPR or better |
VGPR or better assessed according to IMWG criteria assessed by investigator. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or =90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h, or =90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. FLC only: a =90% decrease in the difference between involved and uninvolved FLC levels. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed. |
12 months after the Last Participant In (LPI) i.e., approximately 38 months |
|
| Secondary |
Duration of response (DOR) |
DOR, defined as the time from date of first investigator determined response for achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first. |
12 months after the Last Participant In (LPI) i.e., approximately 38 months |
|
| Secondary |
Time to first response (TT1R) |
TT1R, defined as the time from first isatuximab administration to first investigator-determined response (PR or better) that is subsequently confirmed. |
12 months after the Last Participant In (LPI) i.e., approximately 38 months |
|
| Secondary |
Time to best response (TTBR) |
TTBR, defined as the time from first isatuximab administration to first occurrence of investigator-determined best response (PR or better) that is subsequently confirmed. |
12 months after the Last Participant In (LPI) i.e., approximately 38 months |
|
| Secondary |
Patient experience and Satisfaction Questionnaire v2 (PESQ v2) |
The PESQ v2 has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects and recommendation) and the administration method (comfortability, pain, side effects and overall satisfaction). This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The trial specific version of the PESQ v2 contains of items administered for the duration of treatment. Response options are presented as a 5-point Likert scale ranging from Strongly agree/very satisfied/definitely yes to strongly disagree/very dissatisfied/definitely no. |
Cycle 3/Day 15 and Cycle 6/Day 15 |
|
| Secondary |
Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants |
Blood samples will be collected for assessing the presence of ADA against isatuximab in plasma from only 15 participants. Plasma samples will be screened for antibodies binding to isatuximab and the titer of confirmed positive samples will be reported. |
From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e, approximately up to 15 months (1 cycle = 28 days) |
|
| Secondary |
Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants |
|
Multiple timepoints in Cycle 1 (1 cycle = 28 days) |
|
| Secondary |
Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants |
|
Multiple timepoints in Cycle 1 (1 cycle = 28 days) |
|
