{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"61.2","upperLimit":"148.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"86.0","upperLimit":"146.0","value":"110.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58.5","upperLimit":"148.0","value":"121.4"},{"groupId":"OG001","lowerLimit":"76.7","upperLimit":"141.0","value":"114.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.5","upperLimit":"147.0","value":"121.5"},{"groupId":"OG001","lowerLimit":"68.0","upperLimit":"133.0","value":"109.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"24 Months Post-transplant"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-46.0","upperLimit":"50.0","value":"5.0"},{"groupId":"OG001","lowerLimit":"-33.3","upperLimit":"29.0","value":"7.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Change from Randomization to 6 Months Post-randomization"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-15.0","upperLimit":"49.0","value":"12.6"},{"groupId":"OG001","lowerLimit":"-42.0","upperLimit":"32.8","value":"3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Change from Randomization to 24 Months Post-transplant"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"The FACT-BMT version 4.0 instrument is comprised of the Functional Assessment of Cancer Therapy - General (FACT-G), which evaluates the health-related quality of life (HQL) of patients receiving treatment for cancer, and the BMT Concerns module, that addresses disease and treatment-related questions specific to bone marrow transplant. This scale goes from 0 to 196 where higher scores indicate better functioning. The FACT-BMT Total, which has all items in the FACT-G and BMT modules, was used as the outcome measure. 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":"Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant (BMT) Total Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}