{"groups":[{"description":"Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.","id":"FG000","title":"Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"27"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Unrelated adverse event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Patient underwent autologous transplant"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Moved to compassionate program"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"40"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"}],"type":"Received Cyclophosphamide"},{"achievements":[{"comment":"Completed=still receiving treatment","groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"40"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Of 51 participants enrolled, 40 received treatment. Of those 40, 11 had cyclophosphamide added to their regimens."}