Double Filtration Plasmapheresis Combined With Chemotherapy

NCT ID: NCT04836871

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-10-31

Brief Summary

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

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double filtration plasmapheresis (DFPP) combined with chemotherapy

Group Type EXPERIMENTAL

DFPP combined with chemotherapy

Intervention Type COMBINATION_PRODUCT

Double filtration plasmapheresis combined with chemotherapy

Interventions

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DFPP combined with chemotherapy

Double filtration plasmapheresis combined with chemotherapy

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuling Zhou

OTHER

Sponsor Role lead

Responsible Party

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Fuling Zhou

Head, Division of Hematology; Professor of Hematology; Doctoral advisor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Fuling Zhou, director

Role: primary

+86-02767813137

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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