{"groups":[{"description":"Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.\n\n* Elotuzumab will be administered by intravenous (IV) infusion\n* Bortezomib as a subcutaneous injection\n* Lenalidomide single daily oral dose\n* Dexamethasone as oral tablets and IV infusion\n* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.\n\nSubjects who attain at least a partial response (PR) may elect to stop E-RVD at the end of Induction Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.\n\n\\- The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.\n\nMaintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.\n\nLenalidomide\n\nElotuzumab\n\nBortezomib\n\nDexamethasone\n\nStem Cell Mobilization","id":"FG000","title":"Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Didn't meet criteria for maintenance therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"40"}],"type":"STARTED"},{"achievements":[{"comment":"Of the 40 patients comprising the safety population, 34 patients completed 4 cycles (cycles 1-4) of induction therapy.","groupId":"FG000","numSubjects":"34"}],"type":"Induction Therapy Cycles 1-4"},{"achievements":[{"comment":"Of the 40 patients comprising the safety population, 12 patients completed 4 additional cycles (cycles 5-8) of induction therapy.","groupId":"FG000","numSubjects":"12"}],"type":"Induction Therapy Cycles 5-8"},{"achievements":[{"comment":"Of the 40 patients comprising the safety population, 19 patients received autologous stem cell transplant (ASCT) at the end of Induction cycle 4.","groupId":"FG000","numSubjects":"19"}],"type":"Autologous Stem Cell Transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"29"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Induction Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Patient Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"16"}],"type":"Still on maintenance"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"29"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"}],"type":"NOT COMPLETED"}],"title":"Maintenance Period"}],"recruitmentDetails":"Participants were enrolled from May 2015 to April 2016."}