Clinical trial NCT06228794: The Prognostic Value of CPCs Quantified by Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Circulating plasma cells
Multiparameter flow cytometry
Prognosis
Disease monitoring
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed multiple myeloma patients

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: 2-year progression-free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Rates and depth of response
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hu bei
Study officials:
References: