A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma
NCT ID: NCT02252263
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2014-12-09
2017-10-10
Brief Summary
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Detailed Description
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* Part1: Non-randomized
* Part2: Randomized
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Elotuzumab + Lirilumab
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response
Elotuzumab
Lirilumab
Arm 2: Elotuzumab + Urelumab
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response
Elotuzumab
Urelumab
Interventions
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Elotuzumab
Lirilumab
Urelumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Local Institution
Pamplona, Navarre, Spain
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CA223-028
Identifier Type: -
Identifier Source: org_study_id