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

  • End date
    Jul 1, 2040
  • participants needed
  • sponsor
    Southwest Oncology Group
Updated on 4 March 2022
induction therapy


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.

Condition Multiple Myeloma
Treatment Lenalidomide, Daratumumab/rHuPH20
Clinical Study IdentifierNCT04071457
SponsorSouthwest Oncology Group
Last Modified on4 March 2022


Yes No Not Sure

Inclusion Criteria

Patients must have completed 24 cycles of protocol maintenance with either lenalidomide or lenalidomide + daratumumab/rHuPH20
Patients must have 24-month MRD by NGS test results available and must be MRD negative. Patients whose PCR results are indeterminable will be considered to have positive results
Patients must be in very good partial remission (VGPR) or better by IMWG response criteria (see Section 10.1b)

Exclusion Criteria

Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration
Patients must not have had progressive disease between induction and registration to Registration Step 2. (See Section 10.1b)
Registration Step 3 - Second Randomization (Post 24 Months Maintenance)
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