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

NCT ID: NCT06228794

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Newly diagnosed multiple myeloma cohort

Participants who meet the multiple myeloma diagnostic criteria of IMWG are eligible.

Peripheral blood test

Intervention Type OTHER

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

Interventions

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Peripheral blood test

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

Intervention Type OTHER

Eligibility Criteria

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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

* Received therapy for multiple myeloma.
* Patients diagnosed with monoclonal gammopathy of undetermined significance, smoldering myeloma, nonsecretory myeloma, plasma cell leukemia, amyloidosis, waldenstrom macroglobulinemia or POEMS.
* Imminent or emerging infection.
* Known to be seropositive for a history of HIV.
* A participant is a woman who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial.
* Known or suspected of not being able to comply with the study protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Sun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyan Sun

Role: CONTACT

+8602785726387

Facility Contacts

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Chunyan Sun

Role: primary

+862785726387

Other Identifiers

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UHCT230750

Identifier Type: -

Identifier Source: org_study_id

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