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A Phase 1/2 Study Lenalidomide plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma

Clinical Trial Details

This clinical trial is for men and women with multiple myeloma that requires treatment again after having had at least one prior type of treatment in the past or who did not respond well to previous treatment.

The purpose of the study is to evaluate the correct dosing and effectiveness of a combination of different drugs as treatment for relapsed or refractory myeloma patients when used as a form of high dose chemotherapy before autologous stem cell transplant.

The first drug in the combination is called melphalan. Melphalan is widely used as standard treatment that is given just before an autologous stem cell transplant. The second drug is called lenalidomide, which is FDA-approved in combination with dexamethasone for treatment of multiple myeloma patients who have received one prior therapy. For this study, lenalidomide will be added to the melphalan before an autologous stem cell transplant to determine if it can improve the myeloma response as compared to the standard melphalan-alone conditioning. Although both melphalan and lenalidomide are FDA-approved, the combination of these drugs together as one treatment for multiple myeloma is considered experimental.

The purpose of the Phase 1 portion of this study is to determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT).

The purpose of the Phase 2 portion of this study is to determine whether the addition of high-dose lenalidomide to autologous stem cell transplantation (ASCT) followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).

Key Eligibility: 
  • Men and women age 18 and older
  • Relapsed, primary refractory or relapsed and refractory multiple myeloma
  • Must have received at least one prior line of therapy
  • More detailed eligibility discussed when you contact the study team

Contact

Linda Tegnestam
lit2011@med.cornell.edu
212 746 1480

Primary Investigator

Roger Pearse, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

0909010623

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Study Type

Phase