RecruitingNCT04836871Updated Jul 13, 2023

Double Filtration Plasmapheresis Combined With Chemotherapy

A Phase 1 interventional study of DFPP combined with chemotherapy in Multiple Myeloma, sponsored by Fuling Zhou. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Fuling Zhou · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
Started May 2021; still recruiting 5 years 4 months later.

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Multiple Myeloma

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Fuling Zhou is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Double filtration plasmapheresis (DFPP) combined with chemotherapy
Combination Product: DFPP combined with chemotherapy

Interventions

Combination productDFPP combined with chemotherapy
Double filtration plasmapheresis combined with chemotherapy

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071, China
- Fuling Zhou, director · Contact · zhoufuling@163.com · +86-02767813137
Recruiting

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04836871
Lead sponsor: Fuling Zhou
Responsible party: Fuling Zhou (Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital) — Sponsor-investigator
First posted: Apr 8, 2021
Start date: May 15, 2021
Primary completion: Apr 30, 2024 (estimated)
Completion: Oct 31, 2024 (estimated)
Last update: Jul 13, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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