Multiple Myeloma Clinical Trial

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Summary

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)

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Full Description

Intervention model: Dosing is sequential

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Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria:

Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:

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

Key Exclusion Criteria:

Active multiple myeloma
Monoclonal gammopathy of undetermined significance
Active plasma cell leukemia
Positive for hepatitis B or C virus or HIV infection

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01441973

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 11 Locations for this study

See Locations Near You

Sharp Clinical Oncology Research
San Diego California, 92123, United States
Yale University School Of Medicine
New Haven Connecticut, 06520, United States
Va Connecticut Healthcare System
West Haven Connecticut, 06516, United States
Winship Cancer Institute.
Atlanta Georgia, 30322, United States
University Of Chicago Medical Center
Chicago Illinois, 60637, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis Indiana, 46260, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States
Weill Cornell Medical College
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Mid Dakota Clinic, Pc
Bismarck North Dakota, 58501, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01441973

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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