Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

Conditions

Daratumumab — DRUG
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Lenalidomide — DRUG
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Dexamethasone — DRUG
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

Active Comparator: Experimental Arm: Cycle 1-4 All subjects
Subjects will be treated with the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Experimental: Experimental Arm: Cycle 5+ Partial Response or Better
Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
Active Comparator: Experimental Arm: Cycle 5+ Less than Partial Response
Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Daratumumab Related Infusion Reactions [ Time Frame: 28 days ]

Facility	City	State	ZIP	Site coordinators
University of Rochester Medical Center	Rochester	New York	14642	-

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