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RecruitingNCT06228794Updated May 21, 2025

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

An observational study in Multiple Myeloma, sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Wuhan Union Hospital, China · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
458
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Circulating plasma cells
  • Multiparameter flow cytometry
  • Prognosis
  • Disease monitoring
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 458 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed multiple myeloma patients

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
458 participants (estimated)
Patient registry
No

Groups and cohorts

  • Newly diagnosed multiple myeloma cohort

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

    Other: Peripheral blood test

Interventions

  • OtherPeripheral blood test

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

06

What researchers measure

Primary outcomes

  1. 2-year progression-free survival (PFS)

    To evaluate if there is a correlation between high CPCs level and poor PFS.

    Time frame: 2 years

Secondary outcomes

  1. Rates and depth of response

    To evaluate if there is a correlation between CPCs level and rates and depth of response (IMWG response criteria).

    Time frame: 2 years

  2. Overall survival (OS)

    To evaluate if there is a correlation between high CPCs level and poor OS.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hu bei 430022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06228794
Lead sponsor
Wuhan Union Hospital, China
Responsible party
Chunyan Sun (Professor, Wuhan Union Hospital, China) — Principal investigator
First posted
Jan 29, 2024
Start date
Apr 1, 2024
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
May 21, 2025

Study contacts

Chunyan Sun
Contact
suncy0618@163.com
+8602785726387

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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