Double Filtration Plasmapheresis Combined With Chemotherapy

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836871
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2023
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Combination Product:
• DFPP combined with chemotherapy
Double filtration plasmapheresis combined with chemotherapy

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Fuling Zhou

Country where clinical trial is conducted

China, 

Outcome

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