A Phase I/II Study of Pomalidomide (CC-4047®), Dexamethasone and Romidepsin in Patients with Relapsed or Refractory Multiple Myeloma
Open to Enrollment
This clinical trial is for men and women with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory).
Previous studies have shown that people with myeloma may be more likely to achieve remission when treated with combinations of drugs rather than a single agent. The purpose of this study is to evaluate the use of pomalidomide and dexamethasone with romidepsin in treating relapsed/refractory multiple myeloma.
Pomalidomide inhibits the growth of myeloma cells. It was recently FDA-approved for relapsed/refractory multiple myeloma. Romidepsin (also called Istodax) is a type of drug known as a histone deacetylase (HDAC) inhibitor. It is thought to work by blocking enzymes in cells called histone deacetylases. By blocking these enzymes, romidepsin allows the cells to make important proteins which may cause cancer cells to stop growing or to die. Romidepsin is FDA-approved for treating some types of lymphoma but not for myeloma. Dexamethasone is a steroid and is also FDA-approved. The combination of pomalidomide, romidepsin, and dexamethasone, however, is not FDA-approved and is therefore experimental.
The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone.
In both Phase I and Phase II, participants will receive:
- Pomalidomide daily by mouth on days 1-21 of a 28-day cycle
- Dexamethasone by mouth on days 1, 8, 15 and 22 of a 28-day cycle
- Romidepsin intravenously on days 1 and 15 of a 28-day cycle
Participants in Phase I will receive different doses of romidepsin, depending on when they join the study. Participants in Phase II will receive the maximum tolerated dose of romidepsin (determined in Phase I).
Participants may continue treatment for as long as they are responding to therapy and not experiencing unacceptable side effects.
- Men and women age 18 and older
- Relapsed or refractory multiple myeloma
- Progressive disease after at least 3 prior therapeutic treatments or regimens for myeloma
- Detailed eligibility reviewed when you contact the study team
Linda Tegnestam, R.N.
Phone: (212) 746-1480
Kathleen Pogonowski, R.N.
Phone: (212) 746-6738
Disease Status and/or Stage
Relapsed or Refractory Multiple Myeloma
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