{"groups":[{"description":"Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).","id":"FG000","title":"Elotuzumab + LD in Normal Renal Function(NRF) Participants"},{"description":"Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl \\< 30 ml/min but no dialysis.","id":"FG001","title":"Elotuzumab + LD in Severe Renal Impairment(SRI) Participants"},{"description":"Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.","id":"FG002","title":"Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject request stop study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject decided to move to transplant"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Subject switched to commercial supply"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject plateaued in terms of effect"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Investigator removed subject from study"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject converted to roll-over study"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Subject to receive non-protocol therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"}],"type":"STARTED"},{"achievements":[{"comment":"Completed=treatment on-going","groupId":"FG000","numSubjects":"0"},{"comment":"Completed=treatment on-going","groupId":"FG001","numSubjects":"0"},{"comment":"Completed=treatment on-going","groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"35 participants were enrolled; 9 did not enter into the treatment period. Reasons for not entering treatment period: 8 no longer met criteria, 1 other."}