Participant flow

Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302) · Source last updated 2023-01-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Allogeneic hematopoietic stem cell transplantation (HSCT) and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance Allogeneic 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. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Ixazomib: 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

2. description

   Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance. Allogeneic 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. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Placebo: 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

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         22

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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).

recruitment Details

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.

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Preserved source evidence · Not medical advice