NCT05251896

Brief Summary

To evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with M protein abnormality or renal failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

November 23, 2021

Last Update Submit

July 12, 2023

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaCancerPlasma exchangePlasmapheresis

Outcome Measures

Primary Outcomes (17)

  • Change from M protein content in plasma at Week 18

    M protein content in plasma

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    WBC

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    RBC

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    PLT

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    Hb

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    Sodium ion

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from Blood routine in plasma at Week 18

    Potassium ion

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    eGFR

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    Creatine

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    β2-MG

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    UA

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    ALB

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Change from liver and kidney function at Week 18

    GLB

    Day 0，Day 1，Week 1，Week4，Week 12，Week 18

  • Adverse event: Low blood pressure

    Low blood pressure

    Day 1

  • Adverse event:

    Headache

    Day 1

  • Adverse event: Difficulty breathing

    Difficulty breathing

    Day 1

  • Adverse event: Numbness

    Numbness

    Day 1

Secondary Outcomes (1)

  • Safety and Tolerability Assess patient symptoms

    Day 0，Day 1

Study Arms (1)

Plasma-free procedure

EXPERIMENTAL

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Procedure: Plasma-free procedure

Interventions

Plasma-free procedurePROCEDURE

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Plasma-free procedure

Eligibility Criteria

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

You may qualify if:

  • \. Clinical diagnosis of MM 2. A stable condition after routine treatment 3. Clinical diagnosis of renal insufficiency or M protein abnormalities 4．more than 18 years old 5．With liver and kidney function 6. With normal heart function; 7. Physical condition score 0-2 (ECOG score) 8. Get informed consent from the patient or family member.

You may not qualify if:

  • Allergies or obvious contraindications to any drug;
  • Myocardial infarction and cardiac insufficiency
  • Other malignant tumors
  • TB patients and HIV positive patients 5．Other blood system diseases
  • \. Pregnant or lactating women; 7. Not understand or follow the protocol; 8. Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fuling Zhou

    Wuhan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head,Division of Hematology; Professor of Hematology; Doctoral advisor

Study Record Dates

First Submitted

November 23, 2021

First Posted

February 23, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

CN(1)