drugset / Trial / NCT06697483
Risk Stratification and MRD-driven Maintenance for MM After ASCT
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
Timeline
- Start
- 2024-12-01
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | — | — |
| Subject | Lenalidomide | Other / unclassified | — | — |