Investigating the Prognostic Value of Circulating Plasma Cells in Multiple Myeloma
The Prognostic Value of Circulating Plasma Cells Quantified by Multiparameter Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter Clinical Trial
This study is testing if measuring circulating plasma cells in newly diagnosed multiple myeloma patients can help predict their health outcomes and possibly replace bone marrow tests for monitoring the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 458 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06228794 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prognostic significance of circulating plasma cells (CPCs) in patients newly diagnosed with multiple myeloma. Using advanced multiparameter flow cytometry, the research will identify an optimal threshold for CPC detection and assess its correlation with patient prognosis. Additionally, the study will explore the potential of using CPC detection as a non-invasive alternative to bone marrow aspiration for disease monitoring over time. The trial will involve multiple centers to ensure a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who have been newly diagnosed with multiple myeloma and have not received any prior treatment.
Not a fit: Patients with a history of cancer, those diagnosed with other related conditions, or those currently undergoing treatment for multiple myeloma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive method for monitoring multiple myeloma progression, improving patient comfort and outcomes.
How similar studies have performed: While the use of circulating plasma cells for prognosis in multiple myeloma is a developing area, this specific approach using multiparameter flow cytometry is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full 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.
Where this trial is running
Wuhan, Hubei
- Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Chunyan Sun
- Email: suncy0618@163.com
- Phone: +8602785726387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.