PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
NCT ID: NCT01891643
Last Updated: 2021-07-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2013-09-30
2020-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1: Lenalidomide + Dexamethasone
Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug
Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
Lenalidomide
Dexamethasone
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)
Dexamethasone 28 mg tablets by mouth once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15(cycles 3-18); Day 1 (cycle 19 \& beyond)\]
Dexamethasone 40 mg tablets by mouth once daily \[Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 \& beyond)\]
Dexamethasone 8 mg IV (intravenous) solution once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18); Day 1 (cycle 19 \& beyond)\]
Elotuzumab 10 mg/kg IV solution weekly \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18)\]
Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 \& beyond)
Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
Lenalidomide
Dexamethasone
Elotuzumab
Interventions
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Lenalidomide
Dexamethasone
Elotuzumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
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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Pacific Hematology Oncology Associates
San Francisco, California, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Illinois Cancercare, Pc
Peoria, Illinois, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Medical University Of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Northern Utah Associates
Ogden, Utah, United States
Local Institution
Athens, , Greece
Local Institution
Genova, , Italy
Local Institution
Rome, , Italy
Local Institution
Chorzów, , Poland
Local Institution
Lublin, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
Investigator Inquiry form
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2010-022445-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA204-006 (Biomarker Substudy)
Identifier Type: -
Identifier Source: org_study_id
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