A Phase II Study of Intensive Chemo-Immunotherapy with Salvage Autologous Stem Cell Transplant for Recurrent or Persistent Multiple Myeloma

Full Title

MCT: Phase 2 Trial of Intensive Chemo-immunotherapy with Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Relapsed/Refractory Myeloma in the Context of Salvage Autologous Hematopoietic Cell Transplantation. The 2nd Chance Protocol.

Purpose

Multiple myeloma that has come back despite therapy may be treated with anticancer drugs and/or autologous stem cell transplant. In an autologous stem cell transplant, the stem cells in the body that produce blood are removed and then returned after treatment with chemotherapy. In this study, researchers are evaluating the safety and effectiveness of giving a combination of drugs before and after autologous stem cell transplant in patients with multiple myeloma that has come back or continued to grow despite treatment.

The study drugs to be given before transplant are carfilzomib, lenalidomide, dexamethasone, and daratumumab. After receiving these drugs, patients will receive high-dose melphalan and an autologous stem cell transplant. They will then be given the four drugs again. Researchers hope to learn if this combination of medications can cause remission of myeloma to a level that cannot be detected by even very sensitive tests.

The combination of carfilzomib, lenalidomide, and dexamethasone has already been FDA-approved as a treatment for myeloma that has returned after treatment. Daratumumab has also been FDA approved for patients whose disease has returned after treatment. Giving all four drugs together is investigational, but it has been studied and shown to reduce myeloma well. Carfilzomib and daratumumab are given intravenously (by vein), and lenalidomide and dexamethasone are taken orally (by mouth).

Eligibility

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

  • Patients must have multiple myeloma that came back or continued to grow despite one to three prior regimens of therapy.
  • Patients must be planning to have an autologous stem cell transplant.
  • This study is for patients age 18 to 75.

For more information and to inquire about eligibility for this study, please contact the Bone Marrow Transplant Service consultation line at 877-836-2268.

Protocol

17-493

Phase

I/II

Investigator

Co-Investigators