NCT04836871Unknown1 期
Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
Fuling Zhou1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- M protein clearance rate
研究概览
简要总结
Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma patients who are diagnosed by bone marrow morphology and immunology
- •Patients with stable condition after conventional treatment
- •Patients with renal insufficiency or abnormal M protein
- •Patients over 18 years of age
- •Liver function: blood bilirubin ≤ 35μmol/L, enzymes aspartate transaminase (AST)/aka alanine aminotransferase (ALT) is less than 2 times the upper limit of normal
- •Normal heart function
- •Physical condition score 0-2 level (ECOG score)
- •Obtain an informed consent form signed by the patient or family member
排除标准
- •Allergies or obvious contraindications to any of the drugs involved in the plan
- •Severe heart disease, including myocardial infarction and cardiac insufficiency.
- •Suffering from other organ malignancies
- •Active tuberculosis patients and HIV-positive patients
- •At the same time suffering from other blood system diseases
- •Pregnant or lactating women
- •Able to understand or follow the research plan
- •Past history of intolerance or allergy to similar drugs
- •Patients under 18 years of age
- •Participating in other clinical researchers at the same time
- •There are any other circumstances that hinder the progress of the research
结局指标
主要结局
M protein clearance rate
时间窗: 1hour
before each treatment of Double filtration plasmapheresis (DFPP)
creatinine clearance rate
时间窗: 1hour
before each treatment of DFPP
albumin concentration
时间窗: 1hour
before each treatment of DFPP
serum-free light chain levels
时间窗: 1hour
before each treatment of DFPP
blood urea nitrogen
时间窗: 1hour
before each treatment of DFPP
Platelet concentrations
时间窗: 1hour
before each treatment of DFPP
次要结局
未报告次要终点
研究者
Fuling Zhou
Head, Division of Hematology; Professor of Hematology; Doctoral advisor
Zhongnan Hospital
研究点 (1)
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