An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Change from M protein content in plasma at Week 18
研究概览
简要总结
To evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with M protein abnormality or renal failure.
详细描述
Multiple myeloma (MM) is the second most common hematological tumor after non-Hodgkin's lymphoma. The tumor cells originate from plasma cells in the blood pulp and are classified as plasma cells blood myeloma plasmacytomas by the WHO Tumor. It is characterized by abnormal proliferation of blood medullary plasma cells, accompanied by monoclonal immunoglobulin or light chain. Few patients are classified as non-secretory MM that does not secrete M protein. Multiple myeloma is often accompanied by multiple hemolytic damages, hypercalcemia, anemia, kidney damage, and a serious threat to the patients' lives, health, and quality of life, which have brought a heavy burden to society. Large amounts of M protein pass through the kidneys. At times, it causes acute or chronic renal failure; M protein interferes with the activity of coagulation factors, blocking platelet function, inducing bleeding; and a large amount of M protein can also lead to hyperviscosity syndrome, increase circulatory resistance, and small blood vessel thrombosis Plug, cause various neurological diseases such as blindness, and further aggravate the progression of kidney injury. Patients with hematological myeloma nephropathy already existed at the time of diagnosis, severe patients may die due to renal insufficiency, so the patient was removed immunity globulin in the body to improve the signs of hyperviscosity and clinical symptoms is the focus of clinical research.
In this study, on the basis of previous studies, albumin-free plasma exchange fluid treatment was given to analyze the effects of clinical symptoms, erythrocyte sedimentation rate, blood routine, albumin, renal function, calcium content, and immunoglobulin.
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
- •Clinical diagnosis of MM
- •A stable condition after routine treatment
- •Clinical diagnosis of renal insufficiency or M protein abnormalities 4.more than 18 years old 5.With liver and kidney function
- •With normal heart function;
- •Physical condition score 0-2 (ECOG score)
- •Get informed consent from the patient or family member.
排除标准
- •Allergies or obvious contraindications to any drug;
- •Myocardial infarction and cardiac insufficiency
- •Other malignant tumors
- •TB patients and HIV positive patients 5.Other blood system diseases
- •Pregnant or lactating women;
- •Not understand or follow the protocol;
结局指标
主要结局
Change from M protein content in plasma at Week 18
时间窗: Day 0,Day 1,Week 1,Week4,Week 12,Week 18
M protein content in plasma
Adverse event: Low blood pressure
时间窗: Day 1
Low blood pressure
Adverse event:
时间窗: Day 1
Headache
Adverse event: Difficulty breathing
时间窗: Day 1
Difficulty breathing
Adverse event: Numbness
时间窗: Day 1
Numbness
Change from Blood routine in plasma at Week 18
时间窗: Day 0,Day 1,Week 1,Week4,Week 12,Week 18
WBC
Change from liver and kidney function at Week 18
时间窗: Day 0,Day 1,Week 1,Week4,Week 12,Week 18
eGFR
次要结局
- Safety and Tolerability Assess patient symptoms(Day 0,Day 1)
研究者
Fuling Zhou
Head,Division of Hematology; Professor of Hematology; Doctoral advisor
Zhongnan Hospital
