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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05536700

Enrollment

Registered

2022-09-13

Start date

2021-12-31

Completion date

2022-12-31

Last updated

2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

mass spectrometry, serum immunoglobulin, minimal residual disease, MRD, EasyM, M protein

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Subjects with available baseline and sequential serum samples.

Exclusion criteria

Subjects without baseline and sequential serum samples.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactGang An

angang@ihcams.ac.cn00861350218110

Backup ContactGang An An