Double Filtration Plasmapheresis Combined With Chemotherapy

July 12, 2023 updated by: Fuling Zhou

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double filtration plasmapheresis (DFPP) combined with chemotherapy
Combination product: DFPP combined with chemotherapy
Double filtration plasmapheresis combined with chemotherapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuling Zhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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