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
18 Years
N/A
Both
Smoldering Multiple Myeloma
Trial Information
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
Intervention model: The actual design is sequential (the first 15 patients are in once
monthly dosing, followed by the second cohort of 15 with twice monthly dosing)
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
- Subjects with a confirmed diagnosis of smoldering multiple myeloma according to IMWG
and that is considered high risk according to the following:
- Serum 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
Exclusion Criteria:
- Active multiple myeloma
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The association between Elotuzumab-induced change in monoclonal protein and baseline percentage of CD56dim/CD16+/CD3-/CD45+ Natural Killer (NK) cells in bone marrow
Outcome Time Frame:
Baseline (for NK cells in bone marrow) and once every 4 weeks +/- 7 days (for monoclonal protein)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA204-011
NCT ID:
NCT01441973
Start Date:
February 2012
Completion Date:
May 2014
Related Keywords:
- Smoldering Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| VA Connecticut Healthcare System | West Haven, Connecticut 06516 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
| Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
