A Phase 1b/2a Study of Romidepsin in Combination with Lenalidomide in Adults with Relapsed or Refractory Lymphomas and Myeloma
Open to Enrollment
This clinical trial is for men and women with relapsed or refractory lymphoma or multiple myeloma.
The treatments used to treat relapsed/refractory lymphomas and myeloma do not always work well, or they may only work for a short period of time. New treatments are therefore needed.
This study tests a new combination of drugs, romidepsin and lenalidomide, that are already FDA-approved for treating certain kinds of blood cancers. Romidepsin is an IV infusion. Lenalidomide is a pill taken by mouth. Both of these drugs by themselves have been shown to be effective in treating lymphoma and myeloma. The use of these drugs combined, however, is not FDA-approved and is therefore experimental.
The study has two parts. The first part is a Phase Ib study. In this part of the study, the researchers will determine what the best dose of each drug is when they are given together. Groups of up to 3 participants will receive specific doses of lenalidomide and romidepsin. If the side effects are not too serious, the next group of participants will receive a higher dose of one or both of the drugs.
The second part of the study is called a Phase IIa study. Groups of up to 15 participants with specific types of lymphoma or multiple myeloma will be studied using the doses of each drug determined in the Phase 1b portion to be safe. This part of the study will help determine whether the combination of the drugs is effective in treating lymphoma and myeloma.
Treatment cycles are 28 days. Participants will receive romidepsin via infusion on days 1, 8 and 15 of each cycle. Lenalidomide will be taken by mouth daily for 21 days of each cycle. Participants may continue to receive treatment as long as they are responding to therapy and not experiencing unexpected side effects.
Disease Status and/or Stage
Relapsed or Refractory Lymphoma and Multiple Myeloma
Memorial Sloan-Kettering Cancer Center
- Men and women age 18 and older
- Diagnosed with lymphoma or multiple myeloma
- For Phase IIa portion: must have B-cell lymphoma, T-cell lymphoma or multiple myeloma
- Hodgkin lymphoma eligible for both phases
- Relapsed or refractory disease after at least 1 systemic therapy
- Detailed eligibility reviewed when you contact the study team
- Amelyn Rodriguez, RN
- (212) 746-1362
WCMC IRB #1301013500
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