The Prognostic Value of Circulating Plasma Cells Quantified by Multiparameter Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
2-year progression-free survival (PFS)
时间窗: 2 years
To evaluate if there is a correlation between high CPCs level and poor PFS.
次要结局
- Overall survival (OS)(2 years)
- Rates and depth of response(2 years)
研究者
Chunyan Sun
Professor
Wuhan Union Hospital, China