NCT04836871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

March 7, 2021

Last Update Submit

July 12, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (12)

  • M protein clearance rate

    before each treatment of Double filtration plasmapheresis (DFPP)

    1hour

  • M protein clearance rate

    after each treatment of DFPP

    1hour

  • creatinine clearance rate

    before each treatment of DFPP

    1hour

  • creatinine clearance rate

    after each treatment of DFPP

    1hour

  • albumin concentration

    before each treatment of DFPP

    1hour

  • albumin concentration

    after each treatment of DFPP

    1hour

  • serum-free light chain levels

    before each treatment of DFPP

    1hour

  • serum-free light chain levels

    after each treatment of DFPP

    1hour

  • blood urea nitrogen

    before each treatment of DFPP

    1hour

  • blood urea nitrogen

    after each treatment of DFPP

    1hour

  • Platelet concentrations

    before each treatment of DFPP

    1hour

  • Platelet concentrations

    after each treatment of DFPP

    1hour

Study Arms (1)

Double filtration plasmapheresis (DFPP) combined with chemotherapy

EXPERIMENTAL
Combination Product: DFPP combined with chemotherapy

Interventions

DFPP combined with chemotherapyCOMBINATION_PRODUCT

Double filtration plasmapheresis combined with chemotherapy

Double filtration plasmapheresis (DFPP) combined with chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Division of Hematology; Professor of Hematology; Doctoral advisor

Study Record Dates

First Submitted

March 7, 2021

First Posted

April 8, 2021

Study Start

May 15, 2021

Primary Completion

April 30, 2024

Study Completion

October 31, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)