Study Name: S1803

Recruiting

Multiple Myeloma

S1803 Phase III study of Daratumumab/rHuHPH20(NSC-810307) + Lenalidomide as Post-ASCT Maintenance Therapy in Pt with MM using MRD to direct therapy Duration (DRAMMATIC Study)

NCT#04071457

clinicaltrials.gov/show/NCT04071457

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.

Male and Female – 18 years and older

• Confirmed diagnosis of symptomatic MM w/ Measurable disease at the time of Myeloma diagnosis that required systemic induction therapy prior to ASCT
• Pt who have had ASCT must have initiated induction therapy w/in 18 months prior to transplant and received at least 2 cycles of induction therapy prior to transplant.
• Pt must have completed ASCT w/in 180 days prior to registration
• All ASCT related toxicities must have recovered to < Gr 1

• Smoldering Myeloma
• Pt’s intolerant to starting dose of either Lenalidomide (10 mg) or daratumumab/rHuPH20. Or allergy to any of the study drugs
• Pt’s who have received tandem transplants