Double Filtration Plasmapheresis Combined With Chemotherapy
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DFPP combined with chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Double filtration plasmapheresis (DFPP) combined with chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
M protein clearance rate
before each treatment of Double filtration plasmapheresis (DFPP)
M protein clearance rate
after each treatment of DFPP
creatinine clearance rate
before each treatment of DFPP
creatinine clearance rate
after each treatment of DFPP
albumin concentration
before each treatment of DFPP
albumin concentration
after each treatment of DFPP
serum-free light chain levels
before each treatment of DFPP
serum-free light chain levels
after each treatment of DFPP
blood urea nitrogen
before each treatment of DFPP
blood urea nitrogen
after each treatment of DFPP
Platelet concentrations
before each treatment of DFPP
Platelet concentrations
after each treatment of DFPP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04836871
Brief Title
Double Filtration Plasmapheresis Combined With Chemotherapy
Official Title
Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fuling Zhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double filtration plasmapheresis (DFPP) combined with chemotherapy
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
DFPP combined with chemotherapy
Intervention Description
Double filtration plasmapheresis combined with chemotherapy
Primary Outcome Measure Information:
Title
M protein clearance rate
Description
before each treatment of Double filtration plasmapheresis (DFPP)
Time Frame
1hour
Title
M protein clearance rate
Description
after each treatment of DFPP
Time Frame
1hour
Title
creatinine clearance rate
Description
before each treatment of DFPP
Time Frame
1hour
Title
creatinine clearance rate
Description
after each treatment of DFPP
Time Frame
1hour
Title
albumin concentration
Description
before each treatment of DFPP
Time Frame
1hour
Title
albumin concentration
Description
after each treatment of DFPP
Time Frame
1hour
Title
serum-free light chain levels
Description
before each treatment of DFPP
Time Frame
1hour
Title
serum-free light chain levels
Description
after each treatment of DFPP
Time Frame
1hour
Title
blood urea nitrogen
Description
before each treatment of DFPP
Time Frame
1hour
Title
blood urea nitrogen
Description
after each treatment of DFPP
Time Frame
1hour
Title
Platelet concentrations
Description
before each treatment of DFPP
Time Frame
1hour
Title
Platelet concentrations
Description
after each treatment of DFPP
Time Frame
1hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuling Zhou, director
Phone
+86-02767813137
Email
zhoufuling@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Double Filtration Plasmapheresis Combined With Chemotherapy
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