Mariya Liyasova, Zac McDonald, Paul Taylor, Kathleen Gorospe, Xin Xu, Chenyu Yao, Qixin Liu, Liqiang Yang, Eshetu G Atenafu, Giovanni Piza, Bin Ma, Donna Reece, Suzanne Trudel 

DOI: 10.1158/1078-0432.CCR-21-0649

Publication Summary

M-protein is a well-established biomarker used for multiple myeloma monitoring.  Current improvements in multiple myeloma treatment created the need to monitor minimal residual disease (MRD) with high sensitivity. Measuring residual levels of M-protein in serum by mass spectrometry was established as a sensitive assay for disease monitoring.  The goal of this study was to evaluate the performance of EasyM, a personalized mass spectrometry-based MRD assay, to monitor M-protein levels with high specificity and sensitivity.

Twenty-six patients enrolled in the MCRN-001 clinical trial were selected for the study.  Patients received two high-dose alkylating agents as conditioning followed by lenalidomide maintenance.  All selected patients achieved CR during treatment.  Five patients experienced progressive disease on study.

Key takeaways:

  • Superior Sensitivity: EasyM™ exhibited superior sensitivity, detecting M-protein levels as low as 5.8 x 10⁻⁵ g/dL. This sensitivity surpasses serum protein electrophoresis (SPEP) and immunofixation (IFE) by 1,000- and 200-fold, respectively.
  • Relapse Detection: EasyM™ was able to detect disease progression (a minimum of 2-fold increase in M-protein in any 2 consecutive tests 6 months apart) in 4 of the 5 relapsing patients 2 to 11 months earlier than conventional assays.
  • Monitoring in CR: EasyM™ was able to detect M-protein in 88.89% of available time points with confirmed CR status, highlighting its efficacy in monitoring residual disease in this context.

Tracking M-protein with EasyM™ in MM patients who achieved CR from the MCRN-001 trial. 

Doubling of M-protein over 6 months could predict relapse up to 11 months earlier than conventional testing.

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