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

May 18, 2025 updated by: Chunyan Sun, Wuhan Union Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hu bei
      • Wuhan, Hu bei, China, 430022
        • Recruiting
        • Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed multiple myeloma patients

Description

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 exclusion criteria will not be included in the study.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly diagnosed multiple myeloma cohort
Participants who meet the multiple myeloma diagnostic criteria of IMWG are eligible.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival (PFS)
Time Frame: 2 years
To evaluate if there is a correlation between high CPCs level and poor PFS.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates and depth of response
Time Frame: 2 years
To evaluate if there is a correlation between CPCs level and rates and depth of response (IMWG response criteria).
2 years
Overall survival (OS)
Time Frame: 2 years
To evaluate if there is a correlation between high CPCs level and poor OS.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 18, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT230750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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