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Signed informed consent; age at least 18 years; life-expectancy greater than three months; newly diagnosed, untreated, symptomatic, documented myeloma; and
who are not candidates for high-dose therapy plus SCT because of age (at least 65 years) or coexisting conditions; and measureable disease: serum IgG, IgA, IgM M-protein = 0.5 g/dL or serum IgD M-protein = 0.05 g/dL or = 200 mg urinary M-protein excretion /24-hour.
Must be using two acceptable methods of contraception to avoid pregnancy throughout the study for a period of at least one month (four weeks) before and women for up to eight weeks, men for up to 90 days after the last dose of investigational product; women must not be breastfeeding; subjects must be willing to refrain from blood donations during study drug therapy and for eight weeks after therapy.
To determine if the study drug, elotuzumab, given with lenalidomide and dexamethasone is safe and more effective in killing myeloma cells compared with the standard treatment of lenalidomide and dexamethasone alone.