Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

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Description

PRIMARY OBJECTIVES: I. Establish activity of elotuzumab and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. II. Progression free survival (PFS). SECONDARY OBJECTIVES: I. Progression free survival 2. II. Overall survival. III. Determine inciden...

PRIMARY OBJECTIVES: I. Establish activity of elotuzumab and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. II. Progression free survival (PFS). SECONDARY OBJECTIVES: I. Progression free survival 2. II. Overall survival. III. Determine incidence of secondary primary malignancy. IV. Evaluate the best response rate (stringent complete response [sCR]/very good partial response [VGPR]/partial response [PR]) based on International Myeloma Working Group (IMWG) criteria. V. Evaluate time to progression. VI. Evaluate time to next therapy. VII. Evaluate the tolerability and toxicity. VIII. Perform MD Anderson Symptom Inventory (MDASI)-Myeloma symptom evaluation. OUTLINE: Patients receive elotuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide orally (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

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