Monitoring MRD in Multiple Myeloma in Serum by Mass Spectrometry

NCT07691034 | Not Yet Recruiting

• 2 other identifiers: ID S-20240028Acadra no 24/23555
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Minimal Residual Disease; Multiple Myeloma

Keywords

Minimal Residual Disease; Mass Spectrometry; Flowcytometry; Next Generation Sequencing; Remission

Outcome Measures

Primary Outcomes (1)

• Sensitivity of employed methods

  The sensitivity of the MS-based analysis will be determined. The sensitivity of "high sensitivity flowcytometry" (NGF-MRD) will be determined. The sensitivity of "next generation sequencing" (NGS-MRD) will be determined. The sensitivity of FDG-PET/CT will be determined. Comparison of the sensitivity of the different methods

  From enrollment until 24 months after enrollment of the last patient

Secondary Outcomes (1)

• Progression free survival

  From enrolment until 5 years after last included subject

Other Outcomes (1)

• Feasibility of Mass Spect methods

  From enrollment until 24 months after last patient enrolled

Study Arms (1)

Patients with multiple myeloma in stringent complete remission (sCR)

sCR must have been present for more than 6 months

Diagnostic Test: Mass spectrometry

Interventions

Mass spectrometry DIAGNOSTIC_TEST

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

Also known as: Flowcytometry, Next Generation Sequencing

Patients with multiple myeloma in stringent complete remission (sCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Myeloma patients in stringent complete remission for for than six months

You may qualify if:

• Multiple Myeloma patients in sCR for more than 6 months
• Diagnostic bone marrow and blood/serum material biobanked at diagnosis according to established diagnostic biobank
• Informed, written consent

You may not qualify if:

• Phychiatric disease or other condition where the subject may be non-compliant
• Not able to read and understand Danish language
• Bleeding disorder, thrombocyte counts below 20 mia/L

Sponsors & Collaborators

• Odense University Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma every 3 months for 24 months

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels Abildgaard, MD, professor

  Department Hematology, Odense University Hospital & Department Clinical Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels Abildgaard, MD, professor

CONTACT

+45 2322 1584; niels.abildgaard@rsyd.dk

Charlotte Toftmann Hansen, MD, ass. professor

CONTACT

+45 3053 5733; charlotte.toftmann.hansen1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2035
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share