Minimal Residual Disease negativity after Autologous Hematopoietic Cell Transplantation with lenalidomide maintenance predicts better long-term outcomes in myeloma

1. Achieving Minimal Residual Disease (MRD) negativity at baseline before lenalidomide maintenance, and at one-year post Auto-HCT (AutoHCT) predicts increased progression-free survival in patients with multiple myeloma.

2. MRD-negative status at 1-year post-AutoHCT is associated with improved overall survival.

Evidence Rating Level: 1(Excellent)

Study Rundown: The Prognostic Immunophenotyping in Myeloma Response (PRIMeR) study was a multicentered, prospective trial that enrolled 435 patients to assess if MRD-negative status at baseline, before lenalidomide maintenance therapy, and one year post Auto-HCT, was associated with improved survival outcomes. The study assessed MRD using bone marrow aspirate flow cytometry analysis. Key findings revealed that achieving MRD negativity at baseline, before lenalidomide maintenance therapy, and one year following Auto-HCT was linked to improved progression-free survival (PFS). At one year following Auto-HCT, MRD-negative status was associated with increased overall survival. Strengths include the study’s prospective, multicenter design, while limitations include its observational nature and focus solely on next-generation flow cytometry for MRD assessment, without validating findings with other tools like next-generation sequencing. The findings of this trial overall have significant implications for clinical practice, indicating the potential for MRD assessment to guide treatment decisions and improve patient outcomes in multiple myeloma management.

Click to read the study in the Journal of Clinical Oncology

Relevant Reading: Autologous transplantation, consolidation, and maintenance therapy in multiple myeloma: Results of the BMT CTN 0702 trial.

In-Depth [prospective cohort]: The PRIMeR study prospectively observed and analyzed MRD status using next-generation multiparameter flow cytometry in bone marrow samples from 435 multiple myeloma patients. MRD status was assessed at three distinct time points: baseline/pre-AutoHCT, pre-maintenance, and one year post-AutoHCT. The primary objective was to evaluate MRD-negative status at one year post-AutoHCT and its influence on both progression-free survival (PFS) and overall survival (OS). At baseline, MRD-negative status showed significantly lower progression rates (6-year progression MRD-negative 47% vs. MRD-positive 61%; p = .007) and improved progression-free survival (6-year PFS MRD-negative 49% vs. MRD-positive 37%; p = .022), with no difference in overall survival (6-year OS MRD-negative 75.8% vs. MRD-positive 74.6%; p > .8). In the pre-lenalidomide group, MRD negativity correlated with lower progression rates (5-year progression MRD-negative 45% vs. MRD-positive 68%; p = .001) and better PFS (5-year PFS MRD-negative 52% vs. MRD-positive 30.1%; p < .001), with no difference in OS. Finally, at one year following Auto-HCT, patients who were MRD-negative demonstrated significantly lower progression rates (3-year progression MRD-negative 30.7% vs. MRD-positive 67%; p < .001), improved PFS (3-year PFS MRD-negative 66% vs. MRD-positive 34%; p < .001), and better OS (5-year OS MRD-negative 84% vs. MRD-positive 59%; p < .001). This study underscores the prognostic value of MRD-negativity for progression-free survival at different intervals and overall survival, specifically at one year post-Auto-HCT, in multiple myeloma patients.

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