Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma
Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma
1 other identifier
observational
67
1 country
1
Brief Summary
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (\> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
September 8, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 13, 2022
September 1, 2022
9 months
September 8, 2022
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitative measurement of M protein
Detecting the M protein concentration and its dynamic change curve
From June 6, 2022 to December 31, 2022
Secondary Outcomes (1)
sequence detection of M protein
From December 31, 2021 to May 31, 2022
Eligibility Criteria
Subjects diagnosed with MM.
You may qualify if:
- Subjects with available baseline and sequential serum samples.
You may not qualify if:
- Subjects without baseline and sequential serum samples.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
InsituteHBDH
Tianjin, 300000, China
Related Publications (1)
Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767.
PMID: 38170583DERIVED
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
InstituteHBDH
Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 13, 2022
Study Start
December 31, 2021
Primary Completion
September 17, 2022
Study Completion
December 31, 2022
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share