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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Anticipated): 67

Contacts and Locations

• Study Contact: Name: Gang An; Phone Number: 00861350218110; Email: angang@ihcams.ac.cn
• Study Contact Backup: Name: Gang An An; Phone Number: 00861350218110; Email: angang@ihcams.ac.cn

Study Locations

• China
  • Tianjin, China, 300000
    • Recruiting
    • InsituteHBDH
    • Contact: Gang An, PhD&MD; Phone Number: 008613502181109; Email: angang@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with MM.

Description

Inclusion Criteria:

Subjects with available baseline and sequential serum samples.

Exclusion Criteria:

Subjects without baseline and sequential serum samples.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative measurement of M protein	Detecting the M protein concentration and its dynamic change curve	From June 6, 2022 to December 31, 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sequence detection of M protein	Detecting the M protein sequence in each person	From December 31, 2021 to May 31, 2022

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborators: Shanghai Kuaixu Biotechnology Co., Ltd
• Investigators: Principal Investigator: InstituteHBDH, Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Anticipated): September 17, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: minimal residual disease; mass spectrometry; MRD; serum immunoglobulin; EasyM; M protein
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplastic Processes; Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm, Residual
• Other Study ID Numbers: EasyM-MM-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No