Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/24/2018 |
| Start Date: | December 28, 2011 |
| End Date: | January 17, 2017 |
A Phase 2 Biomarker Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma
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)
patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the
health of the body's immune system)
Intervention model: Dosing is sequential
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
We found this trial at
11
sites
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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