{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Threshold for statistical significance at 0.025.","statisticalComment":"One sided p-value was stratified based on age (\\<75 years versus \\>=75 years) and number of previous lines (2 or 3 versus \\>3) according to IRT.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35.3"},{"groupId":"OG001","value":"60.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\\<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\\<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\\>=90% reduction in serum M-protein plus urine M-protein level \\<100mg/24h/,\\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: \\>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by \\>=90%/\\<200mg/24h,if present at baseline,\\>=50% reduction in the size (SPD) of soft tissue plasmacytomas.","groups":[{"description":"Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).","id":"OG000","title":"Pd (Pomalidomide + Dexamethasone)"},{"description":"Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).","id":"OG001","title":"IPd (Isatuximab + Pomalidomide + Dexamethasone)"}],"paramType":"NUMBER","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)","title":"Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}