{"groups":[{"description":"Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).","id":"FG000","title":"Pd (Pomalidomide + Dexamethasone)"},{"description":"Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).","id":"FG001","title":"IPd (Isatuximab + Pomalidomide + Dexamethasone)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}],"type":"Randomized and not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"22"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"107"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Poor compliance to protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"}],"type":"Physician's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"Treatment extension study"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Unconfirmed disease progression per investigator"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Continue with therapy available commercially"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"154"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"149"},{"groupId":"FG001","numSubjects":"152"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"154"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Randomization was stratified by age (less than \\[\\<\\] 75 years versus greater than and equal to \\[\\>=\\] 75 years) and number of previous lines of therapy (2 or 3 versus more than 3). \"Reason for not completed\" = \"Reason for definitive treatment discontinuation.\"","recruitmentDetails":"The study was conducted at 102 sites in 24 countries. A total of 387 participants were screened between 22 December 2016 and 01 February 2018. Out of which, 307 participants were randomized in 1:1 ratio to IPd (Isatuximab + Pomalidomide + Dexamethasone) and Pd (Pomalidomide + Dexamethasone) arms using an interactive response technology (IRT)."}