Status:
TERMINATED
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Abbott
Conditions:
Newly Diagnosed, Previously Untreated Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the ti...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Subjects who are newly diagnosed with symptomatic MM and who:
- Have not received any prior systemic anti-myeloma therapy
- Have measurable disease
- And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject \<65 years old. There must be a comorbidity that prevents SCT for a subject \<65 years old
Exclusion
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01891643
Start Date
September 30 2013
End Date
June 25 2020
Last Update
July 1 2021
Active Locations (14)
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1
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
2
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
3
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
4
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237