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

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.

NCT Number	NCT04071457
Lead Sponsor	SWOG Cancer Research Network Collaborators: National Cancer Institute (NCI), Janssen, LP
Conditions	Multiple Myeloma
Enrollment	1,100 participants
Start Date	2019-08-13
Primary Completion	2029-07-01 (estimated)
Study Completion	2040-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-15