Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma: A Phase 2 Open-Label Randomized Study by Tristate Consortium
Open to Enrollment
This clinical trial is for men and women with multiple myeloma that has either come back after treatment (relapsed) or has not responded to other treatments (refractory).
The purpose of the study is to see whether pomalidomide reduces the number of myeloma cells in the bones, and to determine the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomide. All patients start by receiving 4 cycles of pomalidomide and dexamethasone. After 4 cycles, study participants will be randomly assigned to one of two treatment groups:
- Group 1: Participants will undergo an autologous stem cell transplant followed by pomalidomide maintenance therapy
- Group 2: Participants will continue to receive pomalidomide and dexamethasone for 5 cycles followed by pomalidomide maintenance therapy
Pomalidomide inhibits the growth of myeloma cells and was recently approved by the FDA for treating relapsed/refractory myeloma. Dexamethasone is approved by the FDA and is often used in combination with other drugs to treat multiple myeloma.
Participants will be in the study for up to 2 years as long as they respond to therapy and do not experience unacceptable side effects. At the end of the study, the two groups will be compared to see if there is a difference in disease outcome.
- Men and women age 18 and older
- Relapsed/refractory multiple myeloma
- Must have been on a minimum of 3 months of maintenance therapy prior to disease progression
- 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/Refractory Multiple Myeloma
Celgene; Memorial Sloan Kettering Cancer Center
WCMC IRB #1303013631
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