The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.
This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates. Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks). Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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
University of Rochester Medical Center
Rochester, New York, United States
Daratumumab Related Infusion Reactions
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.
Time frame: 28 days
Determination of Response Rates
To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen
Time frame: 28 days
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