Real-World Evidence on Prognostic Value of MRD in Multiple Myeloma Using Flow Cytometry.

Area of Science:

• Hematology
• Oncology
• Clinical Research

Background:

• Minimal residual disease (MRD) is a key prognostic factor in multiple myeloma (MM).
• MRD negativity is an early clinical endpoint for drug approval in MM.
• Limited real-world data exists on MRD utility post-treatment.

Purpose of the Study:

• To evaluate the real-world utility of MRD assessment at Day+100 post-autologous stem cell transplantation (ASCT) in newly diagnosed MM patients.
• To correlate MRD status with progression-free survival (PFS) and overall survival (OS).
• To assess the impact of lenalidomide maintenance on MRD-positive and MRD-negative patients.

Main Methods:

• Retrospective multicenter study of 331 newly diagnosed MM patients.
• MRD evaluation at Day+100 after ASCT using flow cytometry (median limit of detection 0.001%).
• Analysis of PFS and OS based on MRD status and lenalidomide maintenance.

Main Results:

• MRD negativity was achieved in 47% of patients.
• MRD negativity significantly prolonged median PFS (49.2 vs. 18.4 months) and OS (not reached vs. 74.9 months).
• MRD-positive patients showed significant PFS benefit from lenalidomide maintenance (18-month PFS: 81% vs. 46%), unlike MRD-negative patients.

Conclusions:

• Real-world MRD assessment at Day+100 post-ASCT is a strong predictor of PFS and OS in MM.
• MRD status is a valuable tool for guiding post-transplant treatment strategies.
• Lenalidomide maintenance therapy offers substantial benefit for MRD-positive MM patients.