Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01441973
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-455
The purpose of this study is to determine if patients with high risk smoldering myeloma who have more CD56dim cells (a marker for the health of the body's immune system) will have better responses to Elotuzumab
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Paul Richardson, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Jacalyn Rosenblatt, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
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)