BMS CA204004: A Phase 3, Randomized, Open-Label Trial of Lenalidomide/dexamethasone with or without Elotuzumab in Relapsed or Refractory Multiple Myeloma
Study Status
Open to Enrollment
Study Description
This is a research study of an experimental drug, called elotuzumab, to treat multiple myeloma. The purpose of this study is to determine if combining elotuzumab with lenalidomide and dexamethasone is more effective at treating relapsed or refractory multiple myeloma than the standard treatment of lenalidomide and dexamethasone alone.
Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. In laboratory studies, elotuzumab was shown to kill myeloma cells, and results of earlier clinical studies in patients with myeloma showed encouraging results when used in combination with lenalidomide and dexamethasone.
Lenalidomide is a drug that changes the immune system, and it may also get in the way of the development of tiny blood vessels that help support tumor growth. Therefore it may reduce or prevent the growth of cancer cells. Lenalidomide in combination with dexamethasone is approved by the FDA for the treatment of patients with multiple myeloma who have received at least 1 prior multiple myeloma therapy. Dexamethasone is a steroid that is commonly used to treat multiple myeloma.
Patients in the study will be randomly assigned to one of two treatment groups. You will be told which group you’ve been assigned to, and there are no placebos used in this study
Control Group (standard treatment):
- Lenalidomide + dexamethasone: lenalidomide by mouth once daily on Days 1 to 21 of each 28-day cycle, and dexamethasone by mouth weekly on Days 1, 8, 15 and 22 of each cycle
Investigational Group:
- Elotuzumab + lenalidomide + dexamethasone: on weeks of elotuzumab dosing (Days 1, 8, 15 and 22 of Cycles 1 and 2, and Days 1 and 15 of subsequent cycles), lenalidomide by mouth once daily on Days 1 to 21 and dexamethasone weekly by mouth + dexamethasone intravenously
You will continue with treatment until your disease gets worse, you have unacceptable side effects, or you and your doctor decide you should no longer receive study treatment.
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Website: http://myelomacenter.org/
Blog: http://myelomacenterblog.com/
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Disease Status and/or Stage
Relapsed or Refractory Multiple Myeloma
Sponsor
Bristol-Myers Squibb
Key Eligibility
- Men and women age 18 and older
- Diagnosed with multiple myeloma
- Have received 1 to 3 prior lines of therapy
- Documented progression from most recent line of therapy
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- The Myeloma Center
- (212) 746-3964
- [email protected]
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
