Lenalidomide/Dexamethasone for Newly Diagnosed Myeloma (2521)
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone with or without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma
|Closed||Multiple Myeloma||Phase III||
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).
Eligibility Criteria (must meet the following to participate in this study)
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
Exclusions (conditions that would prevent participation in this study)
- 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)
Last UpdatedAugust 21, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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