{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.9","upperLimit":"57.5","value":"38.7"},{"groupId":"OG001","lowerLimit":"22.8","upperLimit":"55.0","value":"41.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"PCS: Randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.4","upperLimit":"58.4","value":"47.9"},{"groupId":"OG001","lowerLimit":"23.3","upperLimit":"58.6","value":"41.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"PCS: 6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.9","upperLimit":"58.9","value":"45.1"},{"groupId":"OG001","lowerLimit":"36.6","upperLimit":"58.5","value":"45.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"PCS: 24 Months Post-transplant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.7","upperLimit":"22.4","value":"3.3"},{"groupId":"OG001","lowerLimit":"-15.7","upperLimit":"12.1","value":"1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"PCS: Change from Randomization to 6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-19.8","upperLimit":"29.4","value":"4.7"},{"groupId":"OG001","lowerLimit":"-10.4","upperLimit":"19.4","value":"7.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"PCS: Change from Randomization to 24 Months Post-transplant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.4","upperLimit":"64.3","value":"51.5"},{"groupId":"OG001","lowerLimit":"37.7","upperLimit":"63.3","value":"49.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"MCS: Randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"26.8","upperLimit":"63.4","value":"54.8"},{"groupId":"OG001","lowerLimit":"43.2","upperLimit":"60.8","value":"54.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"MCS: 6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.4","upperLimit":"66.0","value":"56.1"},{"groupId":"OG001","lowerLimit":"22.8","upperLimit":"58.5","value":"49.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"MCS: 24 Months Post-transplant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-18.1","upperLimit":"16.7","value":"-0.6"},{"groupId":"OG001","lowerLimit":"-10.6","upperLimit":"8.2","value":"5.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"MCS: Change from Randomization to 6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.5","upperLimit":"16.6","value":"4.9"},{"groupId":"OG001","lowerLimit":"-32.0","upperLimit":"11.0","value":"-2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"MCS: Change from Randomization to 24 Months Post-transplant"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"The MOS SF-36 instrument is a general assessment of health quality of life with eight components: Physical Functioning, Role Physical, Pain Index, General Health Perceptions, Vitality, Social Functioning, Role Emotional, and Mental Health Index. The scale is 0 to 100 where 0 is maximum disability and 100 is no disability, so the higher the score the more positive the outcome. The Physical Component Summary (PCS) and Mental Component Summary (MCS) were used as the outcome measures in summarizing the SF-36 data for this study. This self-reported questionnaire was completed at transplant, randomization, 6 months following the start of maintenance therapy (which corresponds to 6 months post-randomization), and 24 months post-transplant. Comparisons between treatment groups were performed prior to maintenance, 6 months post-randomization and at 24 months after transplant. Only English and Spanish speaking patients were eligible to participate in the quality of life component of this trial.","dispersionType":"Full Range","groups":[{"description":"Allogeneic 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 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":"OG000","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":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Randomized participants who completed the questionnaire are included.","reportingStatus":"POSTED","timeFrame":"Randomization, 6 months post-randomization, 24 months post-transplant","title":"Medical Outcomes Study (MOS) - Short Form 36 (SF-36) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}