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Double Filtration Plasmapheresis Combined With Chemotherapy

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04836871
Enrollment
20
Registered
2021-04-08
Start date
2021-05-15
Completion date
2024-10-31
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

Interventions

COMBINATION_PRODUCTDFPP combined with chemotherapy

Double filtration plasmapheresis combined with chemotherapy

Sponsors

Fuling Zhou
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
M protein clearance rate1hourbefore each treatment of Double filtration plasmapheresis (DFPP)
creatinine clearance rate1hourbefore each treatment of DFPP
albumin concentration1hourbefore each treatment of DFPP
serum-free light chain levels1hourbefore each treatment of DFPP
blood urea nitrogen1hourbefore each treatment of DFPP
Platelet concentrations1hourbefore each treatment of DFPP

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026