A Phase II Study of Ixazomib as Maintenance Treatment after Allogeneic Stem Cell Transplantation in Patients with High-Risk Multiple Myeloma

Full Title

Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma (BMT CTN 1302)

Purpose

Multiple myeloma has a high risk of returning after treatment. The donation of healthy blood-forming stem cells from a matched donor ("allogeneic stem cell transplantation") is one treatment for this disease. Doctors sometimes use a "reduced-intensity" version of allogeneic transplantation which uses standard chemotherapy drugs at lower doses to reduce the side effects of the treatment, enable the donated stem cells to take hold in the immune system, and allow the low-dose chemotherapy and donated cells to eliminate the myeloma.

In this study, researchers want to see if taking the drug ixazomib as maintenance therapy after the stem cell transplant works better than no maintenance therapy to reduce the risk of multiple myeloma recurrence. All patients in this study will receive a reduced-intensity allogeneic stem cell transplant. They will then be randomly assigned to receive either ixazomib or a placebo (sugar pill) as maintenance therapy, and researchers will compare the two groups.

Ixazomib is taken orally (by mouth). It is approved to treat multiple myeloma that has come back or stopped responding to treatment. Its use in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk multiple myeloma, multiple myeloma that came back after an autologous stem cell transplant, or a fast-growing type of myeloma called plasma cell leukemia.
  • Patients must have a matched donor of peripheral blood stem cells.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study.
  • This study is for patients ages 18 to 65.

For more information about this study and to inquire about eligibility, please contact Dr. Sergio Giralt at 212-639-6009.

Protocol

16-007

Phase

II

Investigator

Co-Investigators

Locations