{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.971","upperLimit":"3.811","value":"2.89"},{"groupId":"OG001","lowerLimit":"1.971","upperLimit":"5.881","value":"3.75"},{"groupId":"OG002","lowerLimit":"2.793","upperLimit":"5.158","value":"3.02"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"PFS: Time interval from the randomization date to the date of the first documented disease progression that is subsequently confirmed or the date of death due to any cause, whichever came first. If progression or death was not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiation of a further anticancer treatment or the analysis cut-off date. Analysis was performed by Kaplan-Meier method. PD (IMWG) criteria: increase of \\>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase \\>=0.5g/dL), serum M-protein increase \\>=1g/dL if lowest M component was \\>=5g/dL; urine M-component (absolute increase \\>=200mg/24h), appearance of new lesion(s),\\>=50% increase from nadir in SPD of \\>1 lesion or \\>=50% increase in the longest diameter of a previous lesion \\>1 cm in short axis or \\>=50% increase in circulating plasma cells (minimum of 200 c/mcL) if that was the only measure of disease.","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":"MEDIAN","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: Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}