A Phase III Study of Carfilzomib, Lenalidomide, and Dexamethasone versus Lenalidomide Alone after Stem Cell Transplant for Multiple Myeloma

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Full Title

UCM15-1286: Phase 3 Randomized trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-Cell Transplant for Multiple Myeloma

Purpose

Carfilzomib is a medication used to treat multiple myeloma that has come back or continued to grow despite prior treatment. However, it is not approved by the U.S. Food and Drug Administration (FDA) for use after a stem cell transplant. Lenalidomide and dexamethasone are used as maintenance therapy after initial treatment for multiple myeloma, and lenalidomide is also FDA-approved for use after stem cell transplant.

In this study, researchers want to determine if using carfilzomib, lenalidomide, and dexamethasone after an autologous (self) stem cell transplant for multiple myeloma is more effective than lenalidomide alone. Patients will be randomly assigned to receive one treatment or the other. Lenalidomide is taken orally (by mouth), dexamethasone is given intravenously (by vein) or taken orally, and carfilzomib is given intravenously.

Eligibility

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

  • Patients must have had a stem cell transplant after no more than two regimens of induction therapy for multiple myeloma.
  • Patients must have at least stable disease within 100 days of transplant.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Oscar Lahoud at 516-256-3995.

Protocol

18-223

Phase

III

Investigator