Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
NCT ID: NCT01441973
Last Updated: 2018-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2011-12-28
2017-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elotuzumab, 20 mg/kg
Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.
Elotuzumab (BMS-901608; HuLuc63)
Elotuzumab, 10 mg/kg
Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.
Elotuzumab (BMS-901608; HuLuc63)
Interventions
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Elotuzumab (BMS-901608; HuLuc63)
Eligibility Criteria
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Inclusion Criteria
* Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
* Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of \<0.125 or \>8.0
* Urine M protein \>200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0
Exclusion Criteria
* Monoclonal gammopathy of undetermined significance
* Active plasma cell leukemia
* Positive for hepatitis B or C virus or HIV infection
18 Years
ALL
No
Sponsors
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AbbVie
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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Sharp Clinical Oncology Research
San Diego, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Va Connecticut Healthcare System
West Haven, Connecticut, United States
Winship Cancer Institute.
Atlanta, Georgia, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States
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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CA204-011
Identifier Type: -
Identifier Source: org_study_id
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