{"analyses":[{"ciLowerLimit":"0.802","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.117","estimateComment":"Two-sided 95% CI estimated using Farrington-Manning method.","groupDescription":"A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority was concluded if lower limit of relative risk 95% CI was greater or equal to 0.6312.","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.0001","paramType":"Relative risk","paramValue":"0.947","statisticalMethod":"Farrington-Manning"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.0"},{"groupId":"OG001","value":"50.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"263"}],"units":"Participants"}],"description":"VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, \\<5% plasma cells in BM aspirates \\& normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;\\>=90% reduction in serum M-protein plus urine M-protein level\\<100mg/24h;\\>=90% decrease in SPD compared to baseline in STP; FLC only:\\>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG000","title":"Isa-IV + Pd"},{"description":"Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG001","title":"Isa-SC + Pd"}],"paramType":"NUMBER","populationDescription":"The ITT population included all randomized population.","reportingStatus":"POSTED","timeFrame":"From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months","title":"Very Good Partial Response or Better Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}