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A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma
- Primary Objective
- To compare the PFS of lenalidomide/dexamethasone + elotuzumab (LdE) versus lenalidomide/dexamethasone (Ld) in subjects with newly diagnosed, previously untreated multiple myeloma (MM).
- Secondary Objectives
- To compare objective response rate between treatment arms
- To compare overall survival between treatment arms
- Exploratory Objectives
- To assess safety in each arm;
- For those subjects who achieve an objective response, to assess the time to tumor response and duration of response;
- To assess the time to subsequent therapy in each arm;
- To assess the Health related Quality of Life (HRQOL) outcomes (EORTC QLQ-C30 and QLQ-MY20) and the Brief Pain Inventory- Short Form (BPI-SF);
- To measure the serum concentrations of elotuzumab in the presence of lenalidomide and dexamethasone;
- To evaluate the immunogenicity of elotuzumab.
- To explore the relationship between the effectiveness of elotuzumab and high risk cytogenetic factors and sMICA levels.
- Subjects who are newly diagnosed with symptomatic Multiple Myeloma 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 Not Available
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