A Phase 3, Randomized Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with multiple myeloma that has not been treated. The study is testing a new experimental drug called elotuzumab.
The purpose of the study is to determine if elotuzumab given with lenalidomide and dexamethasone is more effective in the initial treatment of myeloma compared with the standard treatment of lenalidomide and dexamethasone alone. In addition, the study will evaluate the safety of elotuzumab given with lenalidomide and dexamethasone.
Elotuzumab is a manufactured protein directed against a target found on myeloma cells. Elotuzumab was shown to kill myeloma cells in laboratory studies, and results of earlier clinical trials showed encouraging results when used in combination with lenalidomide and dexamethasone.
Lenalidomide changes the immune systems and may also get in the way of the development of tiny blood vessels that help support tumor growth. Dexamethasone is a steroid commonly used to treat multiple myeloma. Lenalidomide in combination with dexamethasone is FDA-approved for the treatment of people with myeloma who have received prior therapy.
Study participants will be randomly assigned to one of two treatment groups:
- Control Group: Lenalidomide and Dexamethasone
- lenalidomide by mouth once daily on Days 1 to 21 of each 28-day cycle
- dexamethasone by mouth weekly on Days 1, 8, 15 and 22 of each 28-day cycle
- Investigational Group: Elotuzumab, lenalidomide and Dexamethasone
- On weeks of elotuzumab dosing:
- elotuzumab on Days 1, 8, 15 and 22 of Cycles 1 and 2; Days 1 and 15 of Cycles 3 through 18; and Day 1 only of Cycle 19 and beyond
- lenalidomide by mouth once daily on Days 1 to 21
- dexamethasone weekly by mouth + dexamethasone via infusion
- On weeks when elotuzumab is not administered:
- Lenalidomide by mouth once daily on Days 1 to 21 of each cycle
- Dexamethasone by mouth on Days 1, 8, 15 and 22 of each cycle
- On weeks of elotuzumab dosing:
Treatment will continue as long as a participant is responding to therapy and not experiencing uncacceptable side effects.
Disease Status and/or Stage
Untreated Multiple Myeloma
Sponsor
Bristol-Myers Squibb
Key Eligibility
- Age 18 and older
- Diagnosed with multiple myeloma
- No prior therapy for multiple myeloma
Principal Investigator
Contact
- The Myeloma Center
- (212) 746-3964
- [email protected]
Protocol ID
BMS - CA204006
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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]
