Last updated on July 2020

S1803 Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration


Brief description of study

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.

Clinical Study Identifier: NCT04071457

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Alegent Health Mercy Hospital

Council Bluffs, IA United States
2.17miles
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Creighton University Medical Center

Omaha, NE United States
5.16miles
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Nebraska Methodist Hospital

Omaha, NE United States
9.5miles
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Recruitment Status: Open


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