Plasma-free Replacement in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Procedure: Plasma-free procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical diagnosis of MM 2. A stable condition after routine treatment 3. Clinical diagnosis of renal insufficiency or M protein abnormalities 4．more than 18 years old 5．With liver and kidney function 6. With normal heart function; 7. Physical condition score 0-2 (ECOG score) 8. Get informed consent from the patient or family member. Exclusion Criteria: 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 6. Pregnant or lactating women; 7. Not understand or follow the protocol; 8. Allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma-free procedure<br>Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid | Procedure: Plasma-free procedure<br>* Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from M protein content in plasma at Week 18 | M protein content in plasma | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | WBC | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | RBC | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | PLT | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | Hb | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | Sodium ion | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from Blood routine in plasma at Week 18 | Potassium ion | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | eGFR | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | Creatine | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | β2-MG | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | UA | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | ALB | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Change from liver and kidney function at Week 18 | GLB | Day 0，Day 1，Week 1，Week4，Week 12，Week 18 | 
| Adverse event: Low blood pressure | Low blood pressure | Day 1 | 
| Adverse event: | Headache | Day 1 | 
| Adverse event: Difficulty breathing | Difficulty breathing | Day 1 | 
| Adverse event: Numbness | Numbness | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assess patient symptoms | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 0，Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma exchange, Multiple Myeloma, Cancer, Plasmapheresis