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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228794
• Other study ID #: UHCT230750
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2024
• Source: Wuhan Union Hospital, China
• Contact: Chunyan Sun
• Phone: +8602785726387
• Email: suncy0618[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 458
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
China	Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hu Bei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression-free survival (PFS)	To evaluate if there is a correlation between high CPCs level and poor PFS.	2 years
Secondary	Rates and depth of response	To evaluate if there is a correlation between CPCs level and rates and depth of response (IMWG response criteria).	2 years
Secondary	Overall survival (OS)	To evaluate if there is a correlation between high CPCs level and poor OS.	2 years