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
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

Dana-Farber Cancer Institute: Deborah Doss, 617-632-5672,
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)
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