Introduction
Minimal residual disease (MRD) negativity is a key prognostic marker in multiple myeloma (MM), strongly associated with improved progression-free survival (PFS) and overall survival (OS). Current MRD assessments rely on next-generation sequencing (NGS) or next-generation flow cytometry (NGF) from bone marrow, which are invasive and may miss disease due to patchy marrow involvement, hemodilution, and high calibration failure. EasyM is a mass spectrometry-based blood assay that sequences patient-specific M-protein peptides to create a unique “fingerprint,” enabling quantitative tracking of minimal residual disease (MRD) through a non-invasive serum test.
Study Summary
This ongoing prospective, multi-center investigator-initiated study evaluates the clinical utility of EasyM in newly diagnosed multiple myeloma (NDMM) patients, including both transplant-eligible (TE) and transplant-ineligible (TI) populations. Patients were enrolled within four months of treatment initiation and monitored longitudinally with conventional myeloma testing alongside EasyM assessments. EasyM testing was performed at screening and every three months thereafter, with additional timepoints for TE patients following induction therapy and day 100 post-autologous stem cell transplant (ASCT). Bone marrow MRD assessment using NGF (10⁻⁵ sensitivity) was performed once EasyM indicated PRD negativity. As of July 2025, 54 patients had successful identification of a unique clonotypic peptide and were included in the analysis.
Key Findings
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High assay feasibility: Unique clonotypic peptide successfully identified in 54/55 patients (98%)
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Patient characteristics: Median age 61 years; 53% male; majority IgG subtype (74%)
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Treatment status: 68% transplant-eligible, with many already undergoing or planning ASCT
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Post-induction responses (v2):
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83% achieved ≥VGPR
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11 patients SPEP negative, 2 SIFE negative, none PRD negative by EasyM
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Post-ASCT assessments (v3):
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90% ≥VGPR
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EasyM detected residual disease in 4 patients who were SIFE negative, demonstrating higher sensitivity
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Comparison with bone marrow MRD (NGF):
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6/9 patients showed concordance between EasyM and NGF results
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Some discordance observed early in treatment, likely due to delayed M-protein clearance
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Early progression detection: One transplant-ineligible patient demonstrated biochemical progression with rising EasyM and free light chains
Conclusions
Early results from this prospective study suggest that EasyM is a sensitive, non-invasive method for longitudinal monitoring of peripheral residual disease in multiple myeloma. The assay demonstrates strong feasibility, detects residual disease even when conventional serum tests are negative, and shows encouraging concordance with bone marrow MRD by NGF. With longer follow-up, EasyM may play an important role in predicting MRD status, guiding response adapted treatment strategies, and reducing reliance on repeated bone marrow biopsies.
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Authors
Rintu Sharma, Esther Masih-Khan, Harjot Singh Vohra, Sita Bhella, Christine Chen, Chloe Yang, Guido Lancman, Keith Stewart, Vishal Kukreti, Vathany Kulasingam, Abir Khaled, Zac McDonald, Liqiang Yang, Arleigh McCurdy, Suzanne Trudel
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