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NCT05536700 Clinical Trial

Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05536700
Other study ID # EasyM-MM-2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2021
Est. completion date December 31, 2022

Study information
Verified date September 2022
Source Institute of Hematology & Blood Diseases Hospital
Contact Gang An
Phone 00861350218110
Email angang@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 67
Est. completion date December 31, 2022
Est. primary completion date September 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Subjects with available baseline and sequential serum samples. Exclusion Criteria: Subjects without baseline and sequential serum samples.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China InsituteHBDH Tianjin

Sponsors (2)
Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital Shanghai Kuaixu Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitative measurement of M protein Detecting the M protein concentration and its dynamic change curve From June 6, 2022 to December 31, 2022
Secondary sequence detection of M protein Detecting the M protein sequence in each person From December 31, 2021 to May 31, 2022
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