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临床试验/NCT05251896
NCT05251896已完成不适用

An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement

Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2020年1月1日最近更新:
适应症

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

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

发起方
Zhongnan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fuling Zhou

Head,Division of Hematology; Professor of Hematology; Doctoral advisor

Zhongnan Hospital

研究点 (1)

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