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

NCT06228794 | Recruiting

• 1 other identifier: UHCT230750
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Circulating plasma cells; Multiparameter flow cytometry; Prognosis; Disease monitoring

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival (PFS)

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

  2 years

Secondary Outcomes (2)

• Rates and depth of response

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Newly diagnosed multiple myeloma cohort

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

Other: Peripheral blood test

Interventions

Peripheral blood test OTHER

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

Newly diagnosed multiple myeloma cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed multiple myeloma patients

You may qualify if:

• Newly diagnosed multiple myeloma patients.
• Patients without any previous anti-myeloma treatment.
• Age: 18-80years old (adult).
• No history of cancer.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chunyan Sun

CONTACT

+8602785726387; suncy0618@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)