{"groups":[{"description":"Allogeneic hematopoietic stem cell transplantation (HSCT) and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For graft-versus-host disease (GVHD) prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nIxazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.","id":"FG000","title":"Ixazomib Maintenance"},{"description":"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nPlacebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"22"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"20"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Five enrolled participants were not transplanted and an additional 9 participants dropped out of the study prior to randomization for a total of 43 participants who received a transplant and proceeded to randomization. The reasons for no transplant include progression (n=2), toxicity (n=2) and withdrew from study (n=1). The reasons for dropout prior to randomization include death (n=5), progression (n=1), neuropathy (n=1), severe infection (n=1) and withdrew from study (n=1).","recruitmentDetails":"The study opened to accrual on August 17, 2015 and closed to accrual on September 14, 2018 with 57 participants enrolled from 15 participating centers in the United States."}