{"groups":[{"description":"All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"FG000","title":"RVD Alone"},{"description":"All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.\n\nAfter finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"FG001","title":"RVD Plus ASCT"},{"description":"Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"FG002","title":"RVD Cycle 1 Only"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"4"}],"type":"MD or Participant Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"0"}],"type":"Discontinued for other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"357"},{"groupId":"FG001","numSubjects":"365"},{"groupId":"FG002","numSubjects":"7"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"357"},{"groupId":"FG001","numSubjects":"365"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Participants were randomized after 1 cycle of therapy only if cycle 1 therapy was completed and/or participant did not withdraw.","type":"Randomized"},{"achievements":[{"groupId":"FG000","numSubjects":"324"},{"groupId":"FG001","numSubjects":"330"},{"groupId":"FG002","numSubjects":"0"}],"type":"Underwent Stem Cell Mobilization"},{"achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"289"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"76"},{"groupId":"FG002","numSubjects":"7"}],"type":"NOT COMPLETED"}],"title":"Induction and Consolidation"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"156"},{"groupId":"FG001","numSubjects":"102"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"36"},{"groupId":"FG002","numSubjects":"0"}],"type":"MD or Participant Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"0"}],"type":"Discontinued for other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"89"},{"groupId":"FG002","numSubjects":"0"}],"type":"Still on Treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"289"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"108"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"0"}],"comment":"MRD evaluable subset represents participants with clonal sequence identified at baseline plus MRD assessment at start of maintenance.","type":"Minimal Residual Disease (MRD) Evaluable at Maintenance Start"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Given maintenance treatment duration is not fixed, all participants are considered as 'Not Completed'.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"289"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Maintenance"}],"recruitmentDetails":"Participants were enrolled at 56 clinical sites in the U.S. from Oct 1, 2010 to January 30, 2018."}