The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time-to-progression according to circulating plasma cells
研究概览
简要总结
The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.
详细描述
The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.
Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.
Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.
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
- •Diagnosis: Newly diagnosed symptomatic multiple myeloma
- •Signed informed consent
- •No second tumors
排除标准
- •Monoclonal gammopathies of undefined significance
- •Smoldering Multiple Myeloma
- •Plasma cell leukemia
结局指标
主要结局
Time-to-progression according to circulating plasma cells
时间窗: [Time Frame: 3 years]
Measured by cumulative incidence estimates
次要结局
- Progression-free survival([Time Frame: 3 years])
- Overall survival([Time Frame: 3 years])
研究者
Ivan S Moiseev
Vice-director for science R.M. Gorbacheva Memorial Institute for Pediatric Oncology, Hematology and Transplantation
St. Petersburg State Pavlov Medical University