NCT06697483

Risk Stratification and MRD-driven Maintenance for MM After ASCT

Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
DRUG	Lenalidomide	Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-11-20
• Last updated: 2024-11-25

Locations

4 sites across 1 country: China