Status:
COMPLETED
Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
AbbVie
Conditions:
Smoldering Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 im...
Detailed Description
Intervention model: Dosing is sequential
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Key
- 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
- Active multiple myeloma
- Monoclonal gammopathy of undetermined significance
- Active plasma cell leukemia
- Positive for hepatitis B or C virus or HIV infection
Key Trial Info
Start Date :
December 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01441973
Start Date
December 28 2011
End Date
January 17 2017
Last Update
January 23 2018
Active Locations (12)
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1
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
2
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
3
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
4
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322