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Monitoring MRD in Multiple Myeloma in Serum by Mass Spectrometry

NCT07691034 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-08

No results posted yet for this study

Summary

Multiple myeloma (MM) is a severe plasma cell cancer caused by proliferation and accumulation of malignant plasma cells in the bone marrow. Novel therapies have improved responses and survival considerably. Recently, it was shown that achieved and sustained minimal residual disease (MRD) negativity is the best predictor for long-term disease-free and overall survival. Achieving and maintaining MRD negativity will therefore be the new treatment goal for patients with MM. Two methods are established for MRD analysis; next-generation flowcytometry (NGF), e.g., the Euro-MRD flow assay, and next-generation sequencing (NGS), e.g., the ClonoSeq assay. Both methods are highly sensitive, with 10\^-5 as the standard goal, and currently reaching for 10\^-6. Both methods are based on bone marrow sampling, which is inconvenient and painful for the patients, particularly for serial analyses.

Blood-based MRD analyses of high sensitivity would allow more frequent sampling and monitoring. Methods based on circulating free tumor DNA are found to have rather low sensitivity. Mass spectrometry (MS) based analysis of patient-specific M-protein is another potential candidate for sensitive and specific monitoring of patients in deep remission. This method is under development, e.g., at the Mayo Clinic, USA, but is not fully standardized. No commercial assays have been approved.

The investigators will assess and validate the sensitivity of MS-based MRD analyses in monitoring patients with MM in remission. Reproducibility and quality controls will be performed in collaboration with an international partner. The investigators will compare the sensitivity of MS-based analysis with Euro-flow MRD assay and NGS LymphoTrack assay, both performed on bone marrow aspirates. Prospectively, the investigators will monitor a cohort of 40 patients in stringent, complete remission. Imaging by FDG-PET/CT (fluoro-deoxyglucose (FDG) positron-emission tomography (PET) combined with computerized tomography (CT)) is part of MRD assessment according to the International Myeloma Working Group (IMWG) and will be included in our studies.

Establishing a blood based MRD analysis will potentially not only be more convenient, it may, in some patients, be more sensitive. The blood reflects disease status in the whole body, whereas bone marrow sampling only allows examining what is present at this particular site. MRD in MM may be patchily located in the skeleton, highlighting the relevance of including FDG PET/CT in the assessment.

Conditions

Interventions

DIAGNOSTIC_TEST

Mass spectrometry

M-protein/Kappa/Lambda in serum will be measured by Mass Spectrometry (MS) using two different methods: 1) a clonotypic method based on sequencing of clonal Ig rearrangement, and 2) an intact protein measurement based reversed-phase liquide chromatography and detection by high resolution Orbitrap MS. Samples will be analyzed using both methods for increased sensitivity and specificity and the finding will be compared by minimal residual disease measurements by high sensitive flowcytometry, next generation sequencing, and FDG-PET/CT

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Niels Abildgaard, MD, professor · Department Hematology, Odense University Hospital & Department Clinical Research, University of Southern Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-04
Primary Completion
2029-01-31
Completion
2035-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691034 on ClinicalTrials.gov