Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Status: Recruiting
Phase: Phase 3
Diagnosis: Multiple Myeloma
NCT ID: NCT01335399
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-270
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Overall PI:
Jacob Laubach, 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 who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation because
of age (≥ 65 years) or coexisting conditions
Exclusion Criteria:
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)