Double Filtration Plasmapheresis Combined With Chemotherapy

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Combination Product: DFPP combined with chemotherapy

• Registration Number: NCT04836871
• Lead Sponsor: Fuling Zhou

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-05-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double filtration plasmapheresis (DFPP) combined with chemotherapy	DFPP combined with chemotherapy	-

Primary Outcome Measures

Name	Time	Method
serum-free light chain levels	1hour	after each treatment of DFPP
albumin concentration	1hour	after each treatment of DFPP
Platelet concentrations	1hour	after each treatment of DFPP
M protein clearance rate	1hour	after each treatment of DFPP
creatinine clearance rate	1hour	after each treatment of DFPP
blood urea nitrogen	1hour	after each treatment of DFPP

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China