S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Status:
Recruiting
Trial end date:
2040-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Southwest Oncology Group
Collaborators:
Adaptive Janssen, LP National Cancer Institute (NCI)