A Phase 1 Open-Label Study of the Safety and Efficacy of PD 0332991 (Palbociclib) in Combination with Lenalidomide and Dexamethasone 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).
The purpose of the study is to determine the effectiveness of the combination of PD 0332991, lenalidomide and dexamethasone (PLD) in treating relapsed/refractory multiple myeloma.
PD 0332991 is an experimental drug and is a pill taken by mouth. It works by blocking specific growth signals within cancer cells. Lenalidomide (also called Revlimid) is approved for use with dexamethasone for people with multiple myeloma who have received prior therapy.
Study participants will receive different doses of PD 0332991 and lenalidomide depending on when they enroll in the study. The study will help determine the maximum tolerated dose of the combination of the study drugs.
Treatment schedule (treatment cycles are 28 days):
- PD 0332991 daily for Days 1-14 of each cycle
- Lenalidomide daily for Days 8-21 (or Days 1-21, depending on dose level ) of each cycle
- Dexamethasone on Days 1, 8, 15 and 22 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
- Relapsed or refractory multiple myeloma
- Progression of disease after prior therapy or lack of response to current therapy
- 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
WCMC IRB # 1306014004
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