Phase 1b/3 Multicenter Study of Oprozomib, Pomalidomide, and Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Myeloma Subjects
Open to Enrollment
This clinical trial is for men and women with multiple myeloma that has recurred despite treatment (relapsed) or did not respond to treatment (refractory). The study is evaluating an experimental drug called oprozomib. Oprozomib is taken orally and will be given at different dose levels in combination with pomalidomide and dexamethasone.
Oprozomib works by preventing the breakdown of certain proteins in cell, causing the cells to die. Cancer cells are more susceptible to these effects than normal cells. Pomalidomide is designed to change the immune system, which may interfere with the development of blood vessels that help support tumor growth. Dexamethasone is a steroid that reduces inflammation. Pomalidomide and dexamethasone are FDA-approved.
The study has two parts—Phase 1b followed by Phase 3. We are currently enrolling for the Phase 1b study.
In Phase 1b, participants will receive different dose levels of oprozomib and pomalidomide to determine the best dose levels to use in combination with dexamethasone. All participants will receive oprozomib, pomalidomide and dexamethasone.
Treatment cycles are 28 days. Participants will receive:
- Oprozomib (or placebo in Phase 3, Group 2) once daily on Days 1-5 and 15-19 of each cycle
- Pomalidomide on Days 1-21 of each cycle
- Dexamethasone on Days 1-2, 8-9, 15-16 and 22-23 of each cycle
Participants will continue on study treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
- Men and women age 18 and older
- Multiple Myeloma
- Relapsed/refractory after at least 2 lines of standard therapy including:
- 2 consecutive cycles of both bortezomib (Velcade) and lenalidomide or thalidomide
- 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
Primary Refractory or Relapsed and Refractory Multiple Myeloma
WCMC IRB # 1310014409
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