{"groups":[{"description":"Participants received carfilzomib 20 milligrams per meter square (mg/m\\^2), intravenous (IV) infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 milligrams (mg), orally (PO) or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).","id":"FG000","title":"Carfilzomib + Dexamethasone (Kd)"},{"description":"Participants received isatuximab 10 milligrams per kilogram (mg/kg), IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).","id":"FG001","title":"Isatuximab + Carfilzomib + Dexamethasone (IKd)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"29"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"86"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"21"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"24"}],"type":"Treatment extension study"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Randomized and not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}],"type":"Study discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"12"}],"type":"Others"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"179"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"177"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"179"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"First result analysis (A) reported was for a data cut-off date of 7 Feb 2020 for efficacy outcomes, 14 Jan 2022 for CR, MRD and PFS2. PFS data was reported at both cut-off dates: 7 Feb 2020 \\& 14 Jan 2022. Primary A of PFS refers to planned interim A conducted at 103 events (death/PD) with cut-off date 7 Feb 2020 \\& Final A of PFS conducted at 159 events with cut-off date 14 Jan 2022. Data cut-off for overall survival and LPLV was 7 Feb 2023 and 3 Jan 2025, respectively.","recruitmentDetails":"Study was conducted at 69 active centers in 16 countries. A total of 341 participants were screened between 25 October 2017 and 21 March 2019, of which 39 participants were screen failure due to not meeting eligibility criteria. Randomization was stratified by number of prior lines (1 versus \\>1) \\& revised international staging system (R-ISS) I or II versus III versus not classified. Reason for not completed = Reason for definitive treatment discontinuation."}