CMMY19113 / S1803 / Brea LipeResearch Question:
Does treating multiple myeloma patients with two drugs Daratumumab and Lenalidomide
help them become negative for the disease?
Basic Study Information
Purpose:Location: University of Rochester Medical Center
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to
Reg Step 2. Patients are followed until they will begin Maintenance and then registered
to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide
for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance,
MRD is assessed to guide further therapy. MRD-positive patients will continue with
the assigned treatment. MRD-negative patients will be further randomized (Reg Step
3) to either continue or discontinue the assigned treatment. Patients are treated
for up to 7 years from Step 2 reg and followed for up to 15 years.
Study Reference #: CMMY19113
Lead Researcher (Principal Investigator)
Study Contact InformationStudy Coordinator: Lisa Metzger
Additional Study Details
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