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.
Description
The purpose of this study is to compare the usual maintenance treatment alone (lenalidomide until the disease progresses or you cannot tolerate it) to using the drug daratumumab/rHuPH20 plus the usual treatment. The addition of daratumumab/rHuPH20 to the
usual treatment could help you live longer after your stem cell transplant. But, it could also cause side effects.
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding daratumumab/rHuPH20 increases the life of patients by 6 years or more compared to the usual approach.
Principal Investigator
Study Coordinator
Research Contact
Jongie Shelton - jongie.shelton@vandaliahealth.org