Double Filtration Plasmapheresis Combined With Chemotherapy

Study Overview
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Brief Summary
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Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma.

Official Title
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Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Combination Product: DFPP combined with chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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: Double filtration plasmapheresis (DFPP) combined with chemotherapy<br> | Combination Product: DFPP combined with chemotherapy<br>* Double filtration plasmapheresis combined with chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M protein clearance rate | before each treatment of Double filtration plasmapheresis (DFPP) | 1hour | 
| M protein clearance rate | after each treatment of DFPP | 1hour | 
| creatinine clearance rate | before each treatment of DFPP | 1hour | 
| creatinine clearance rate | after each treatment of DFPP | 1hour | 
| albumin concentration | before each treatment of DFPP | 1hour | 
| albumin concentration | after each treatment of DFPP | 1hour | 
| serum-free light chain levels | before each treatment of DFPP | 1hour | 
| serum-free light chain levels | after each treatment of DFPP | 1hour | 
| blood urea nitrogen | before each treatment of DFPP | 1hour | 
| blood urea nitrogen | after each treatment of DFPP | 1hour | 
| Platelet concentrations | before each treatment of DFPP | 1hour | 
| Platelet concentrations | after each treatment of DFPP | 1hour |