{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.30","upperLimit":"27.45","value":"11.8"},{"groupId":"OG001","lowerLimit":"12.12","upperLimit":"42.20","value":"25.0"},{"groupId":"OG002","lowerLimit":"10.12","upperLimit":"39.15","value":"22.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"ORR by Investigator using international myeloma working group (IMWG) response criteria:percentage of participants with complete response (CR) (including stringent CR \\[sCR\\]very good partial response \\[VGPR\\] and partial response \\[PR\\]).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,less than (\\<)5% plasma cells in bone marrow (BM) aspirates and normal free light chain(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/24hour(h);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 \\<200mg/24h.In addition to above, if present at baseline,\\>=50% reduction in size (sum of products of maximal perpendicular diameters of measured lesions \\[SPD\\]) of soft tissue plasmacytomas required.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG000","title":"Phase 2: Isatuximab"},{"description":"Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG001","title":"Phase 2: Isatuximab + CemiplimabQ2W"},{"description":"Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG002","title":"Phase 2: Isatuximab + CemiplimabQ4W"}],"paramType":"NUMBER","populationDescription":"The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months","title":"Phase 2: Percentage of Participants With Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}