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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated People's Hospital of Ningbo University

About this trial

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.

Eligibility criteria

Qualifiers

1. Patients newly diagnosed as multiple myeloma.

2. Indication for ASCT.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.

4. Life expectancy ≥ 3 months.

Disqualifiers

1. Cardiac function class II or higher or cardiac ejection fraction <40%.

2. Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN).

3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN.

4. Serum creatinine clearance rate≤30%.

Trial design

Treatments tested in this trial

  • Etoposide
  • Cytarabine
  • Pegfilgrastim
  • Cyclophosphamide
  • G-CSF
  • G-CSF

Treatment groups

99 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Affiliated People's Hospital of Ningbo University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

The Central Hospital of Lishui City

Collaborator

Jinhua People's Hospital

Collaborator

Shaoxing People's Hospital

Collaborator

Shaoxing Second Hospital

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

Taizhou Hospital

Collaborator

Dongyang People's Hospital

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

Huizhou Municipal Central Hospital

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Jinhua Municipal Central Hospital

Collaborator