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The Prognostic Value of CPCs Quantified by Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter Clinical Trial

The Prognostic Value of Circulating Plasma Cells Quantified by Multiparameter Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06228794
Enrollment
458
Registered
2024-01-29
Start date
2024-04-01
Completion date
2027-12-01
Last updated
2025-05-21

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Circulating plasma cells, Multiparameter flow cytometry, Prognosis, Disease monitoring

Brief summary

This study aims to investigate the prognostic value of circulating plasma cells (CPCs) in patients with multiple myeloma and explore whether CPCs detection might be used in place of bone marrow aspiration for disease monitoring.

Detailed description

Circulating plasma cells (CPCs) represents a phenotypic subset of bone marrow multiple myeloma (MM) cells, which would contribute to the progression and dissemination of the tumor. High-sensitivity techniques such as multiparameter flow cytometry provide a tool for better detection of CPCs; however, a clear threshold has not been identified. The primary objective of the current study is to identify an optimal threshold for CPCs quantified by 8-color flow cytometry (with antibodies to CD38, CD138, CD45, CD56, CD19, CD27 and cytoplasmic kappa and lambda immunoglobulin light chains) and determine the specific relationship between CPCs level and the prognosis of MM. In addition, the evaluation of CPCs at multiple time points will be performed to explore whether CPCs detection might be used in place of bone marrow aspiration for disease monitoring.

Interventions

We will draw 2-5 mL of peripheral blood and utilize multiparameter flow cytometry to measure the level of circulating plasma cells.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients must meet all of the following inclusion criteria. * Newly diagnosed multiple myeloma patients. * Patients without any previous anti-myeloma treatment. * Age: 18-80years old (adult). * No history of cancer. * Informed consent.

Exclusion criteria

Patients meeting any of the following

Design outcomes

Primary

MeasureTime frameDescription
2-year progression-free survival (PFS)2 yearsTo evaluate if there is a correlation between high CPCs level and poor PFS.

Secondary

MeasureTime frameDescription
Rates and depth of response2 yearsTo evaluate if there is a correlation between CPCs level and rates and depth of response (IMWG response criteria).
Overall survival (OS)2 yearsTo evaluate if there is a correlation between high CPCs level and poor OS.

Countries

China

Contacts

Primary ContactChunyan Sun
suncy0618@163.com+8602785726387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026