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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06228794
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wuhan Union Hospital, China
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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, CD117 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.

Arms & Interventions

Arms

: Newly diagnosed multiple myeloma cohort

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Wuhan, Hu Bei, China

Status

Recruiting

Address

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

Wuhan, Hu Bei, 430022

Site Contact

Chunyan Sun

suncy0618@163.com

+862785726387