Phase 3 trials using MRD status to guide intensification or deintensification of therapy
| Title . | Intervention/description . | Phase . | Estimated primary completion date . | Primary end point . | Brief outline . |
|---|---|---|---|---|---|
| NCT04071457 DRAMMATIC study | Drug: lenalidomide Drug: daratumumab/rHuPH20 | Phase 3 | 1 July 2029 | Overall survival | After 2 years of maintenance, MRD+ patients continue with the assigned treatment. MRD− patients are randomized to continue/discontinue treatment. |
| NCT04513639 REMNANT study | Drug: early treatment of relapse with carfilzomib, dexamethasone, daratumumab Drug: standard treatment of relapse with carfilzomib, dexamethasone, daratumumab | Phase 2-3 | 1 June 2030 | PFS, OS, MRD negativity after first-line treatment | Newly diagnosed patients are treated with standard induction. Patients that reach MRD negativity are randomized to early treatment after conversion to MRD+ vs treatment after progression as defined by IMWG. |
| Title . | Intervention/description . | Phase . | Estimated primary completion date . | Primary end point . | Brief outline . |
|---|---|---|---|---|---|
| NCT04071457 DRAMMATIC study | Drug: lenalidomide Drug: daratumumab/rHuPH20 | Phase 3 | 1 July 2029 | Overall survival | After 2 years of maintenance, MRD+ patients continue with the assigned treatment. MRD− patients are randomized to continue/discontinue treatment. |
| NCT04513639 REMNANT study | Drug: early treatment of relapse with carfilzomib, dexamethasone, daratumumab Drug: standard treatment of relapse with carfilzomib, dexamethasone, daratumumab | Phase 2-3 | 1 June 2030 | PFS, OS, MRD negativity after first-line treatment | Newly diagnosed patients are treated with standard induction. Patients that reach MRD negativity are randomized to early treatment after conversion to MRD+ vs treatment after progression as defined by IMWG. |
IMWG, International Myeloma Working Group.