{"analyses":[{"ciLowerLimit":"0.903","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.126","estimateComment":"Two-sided 95% CI estimated using Farrington-Manning method.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority was concluded if lower limit of relative risk 95% confidence interval (CI) was greater or equal to 0.839.","nonInferiorityType":"NON_INFERIORITY","pValue":"0.0006","paramType":"Relative risk","paramValue":"1.008","statisticalMethod":"Farrington-Manning"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.5"},{"groupId":"OG001","value":"71.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"263"}],"units":"Participants"}],"description":"ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \\& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\\<5% plasma cells in bone marrow (BM) aspirates \\& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \\& urine M-protein detectable by immunofixation, not electrophoresis;\\>=90% reduction in serum M-protein plus urine M-protein level\\<100mg/24hour(h);\\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \\>=90% or to \\<200mg/24h.In addition to above, if present at baseline,\\>=50% reduction in size SPD of STPs also required.","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 intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \\[IRT\\]). Percentages are rounded off to the tenth decimal place.","reportingStatus":"POSTED","timeFrame":"From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months","title":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}