Status:
COMPLETED
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
AbbVie
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Documented progression from most recent line of therapy
- 1-3 prior lines of therapy
- Measurable disease
- Life expectancy ≥3 months
- Prior treatment with Lenalidomide permitted if:
- Best response achieved was ≥Partial Response (PR)
- Patient was not refractory
- Patient did not discontinue due to a Grade ≥3 related adverse event
- Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Exclusion
- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Key Trial Info
Start Date :
June 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT01239797
Start Date
June 20 2011
End Date
April 21 2021
Last Update
June 1 2022
Active Locations (216)
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1
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States, 35661
2
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
3
Local Institution
Berkeley, California, United States, 94704
4
Local Institution
Burbank, California, United States, 91505