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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
Fuling Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 7, 2021
Last Updated
July 12, 2023
Sponsor
Fuling Zhou
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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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