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Protocol No. BMTCTN1302

Principal Investigator Hall, Aric

Phase II

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed

Title Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma

Objective Because maintenance treatment (chemotherapy) is given to slow the return of multiple myeloma (MM) after an allogeneic transplant we are doing this study to learn if maintenance treatment works better to control your disease than a placebo (a pill that doesn't have any drugs, like a sugar pill). We are doing this study to learn more about ways to prevent or delay the return (relapse) of multiple myeloma after an allogeneic transplant.

Treatment This study includes a conditioning regimen (chemotherapy to help kill cancer cells) first, then a peripheral blood stem cell (PBSC) transplant, and then assignment to one of two groups for post-transplant maintenance therapy. For this study, the type of allogeneic transplant you will get is called a peripheral blood stem cell (PBSC) transplant. Your doctor also wants to use a reduced-intensity or non-myeloablative conditioning regimen for your transplant.

Description In this study, we will use 2 treatments to see which one is better at preventing or delaying relapse of multiple myeloma (MM). We will use a computer program to assign you by chance to treatment group A or B. You will have an equal chance of being placed in either group. Both Study Treatment Groups (A+B) will receive the same treatment before the allogeneic peripheral blood stem cell (PBSC) transplant, and the same treatment after the transplant to prevent Graft versus Host Disease (GVHD). Treatment Group A will receive Ixazomib (an experimental maintenance pill). Ixazomib will consist of 12 x 28-day cycles at a dose of 3 mg on Days 1, 8 and 15, with adjustments depending on toxicity. Treatment Group B will receive a placebo (no maintenance) and will follow the same treatment and dose schedule as those randomized to Ixazomib maintenance.

Key Eligibility
  • Patients must be aged > 18.0 years and < 66.0 years of age at the time of enrollment
  • Patients must have high risk multiple myeloma, standard risk multiple myeloma or plasma cell leukemia
  • Patients must have a HLA-matched related or unrelated donor willing to donate peripheral blood progenitor cells

Applicable Disease Sites Multiple Myeloma

Therapies Involved Bone Marrow Transplant; Cytotoxic Chemotherapy

Drugs Involved Bortezomib; PS341 (Bortezomib); Velcade (Bortezomib); alkeran (melphalan); f-ara-amp (fludarabine); flamp (fludarabine); fludara (fludarabine); fludarabine; ixazomib; lpam (melphalan); melphalan; placebo

Status Open

Participating Institutions UW Hospital and Clinics