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

Summary

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

• Multiple Myeloma
• Hematopoietic Stem Cell Mobilization

Interventions

DRUG

Etoposide

Day 1\~Day 2: 75mg/m\^2

DRUG

Cytarabine

Day 1\~Day 2: 200g/m\^2, q12h

DRUG

Pegfilgrastim

Day 6: 6mg

DRUG

Cyclophosphamide

Day 1\~Day 2: 1～2g/m\^2

DRUG

G-CSF

Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.

DRUG

G-CSF

Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Jinhua People's Hospital

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• Shaoxing Second Hospital

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Jinhua Municipal Central Hospital

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  lead OTHER_GOV

Principal Investigators

• Ying Lu · The Affiliated People's Hospital of Ningbo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-31

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations