Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06520176

Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients

Led by The Affiliated People's Hospital of Ningbo University · Updated on 2024-07-25

99

Participants Needed

16

Research Sites

121 weeks

Total Duration

On this page

Sponsors

T

The Affiliated People's Hospital of Ningbo University

Lead Sponsor

F

First Affiliated Hospital of Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.

CONDITIONS

Official Title

Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients newly diagnosed with multiple myeloma
  • Eligible for autologous stem cell transplantation (ASCT)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Life expectancy of at least 3 months
  • Ability to understand the study protocol and provide informed consent
Not Eligible

You will not qualify if you...

  • Cardiac function class II or higher or ejection fraction below 40%
  • Serum direct bilirubin above twice the upper limit of normal
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper limit of normal
  • Serum creatinine clearance rate 30% or less
  • Presence of active infection
  • Previous hematopoietic stem cell mobilization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Dongyang People's Hospital

Dongyang, Zhejiang, China

Actively Recruiting

2

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Actively Recruiting

3

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Actively Recruiting

4

Huzhou central hospital

Huzhou, Zhejiang, China

Actively Recruiting

5

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Actively Recruiting

6

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Actively Recruiting

7

Jinhua People's Hospital

Jinhua, Zhejiang, China

Actively Recruiting

8

Lishui Central Hospital

Lishui, Zhejiang, China

Actively Recruiting

9

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Actively Recruiting

10

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Actively Recruiting

11

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Actively Recruiting

12

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

Actively Recruiting

13

Taizhou Central Hospital

Taizhou, Zhejiang, China

Actively Recruiting

14

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Actively Recruiting

15

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Actively Recruiting

16

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Actively Recruiting

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Research Team

Y

Ying Lu

CONTACT

P

Peipei Ye

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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