Double Filtration Plasmapheresis Combined With Chemotherapy

• Sponsor: Fuling Zhou (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04836871
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 41.6
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Combination Product: DFPP combined with chemotherapy	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
• Actual Study Start Date: May 15, 2021
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double filtration plasmapheresis (DFPP) combined with chemotherapy	Combination Product: DFPP combined with chemotherapy; Double filtration plasmapheresis combined with chemotherapy

Outcome Measures

Primary Outcome Measures

1. M protein clearance rate [1hour]

   before each treatment of Double filtration plasmapheresis (DFPP)

2. M protein clearance rate [1hour]

   after each treatment of DFPP

3. creatinine clearance rate [1hour]

   before each treatment of DFPP

4. creatinine clearance rate [1hour]

   after each treatment of DFPP

5. albumin concentration [1hour]

   before each treatment of DFPP

6. albumin concentration [1hour]

   after each treatment of DFPP

7. serum-free light chain levels [1hour]

   before each treatment of DFPP

8. serum-free light chain levels [1hour]

   after each treatment of DFPP

9. blood urea nitrogen [1hour]

   before each treatment of DFPP

10. blood urea nitrogen [1hour]

    after each treatment of DFPP

11. Platelet concentrations [1hour]

    before each treatment of DFPP

12. Platelet concentrations [1hour]

    after each treatment of DFPP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430071

Sponsors and Collaborators

• Fuling Zhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT04836871
• Other Study ID Numbers: DFPPv1.0
• First Posted: Apr 8, 2021
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 16, 2021