A Phase IB/IIA Study of Romidepsin plus Lenalidomide in Adults with Relapsed or Refractory Lymphoma and Myeloma

Protocol
12-170
Full Title
A Phase Ib/IIa Study of Romidepsin in Combination with Lenalidomide in Adults with Relapsed or Refractory Lymphomas and Myeloma
Phase
I/II
Disease Status
Relapsed/Refractory
Purpose

Despite currently available treatments for lymphoma and multiple myeloma, many patients experience a relapse of their disease. Doctors are therefore seeking more effective therapies. The purpose of this study is to evaluate the combination of two currently available therapies — romidepsin and lenalidomide — in patients with lymphoma or multiple myeloma that has returned or persisted despite prior therapy.

Romidepsin is a drug that is approved to treat cutaneous T-cell lymphoma in patients who have already received a regimen of prior therapy. Lenalidomide is approved for treating multiple myeloma and myelodysplastic syndromes. This study marks the first time these two drugs will be evaluated together.

Eligibility

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

  • Patients must have lymphoma or multiple myeloma that has returned or persisted despite one regimen of prior chemotherapy.
  • At least 3 weeks must have passed since completion of prior chemotherapy and 2 weeks since radiation therapy, hormonal therapy, or surgery and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.

Disease(s)
Hematology: Multiple Myeloma
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations