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Recruiting NCT06520176

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

Phase III Interventional Multiple Myeloma Hematopoietic Stem Cell Mobilization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Etoposide, Cytarabine, Pegfilgrastim, Cyclophosphamide.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Hematopoietic Stem Cell Mobilization. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients

Overview

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.

Detailed description

According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells \>5×10\^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells \>2×10\^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.

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.

Primary outcome measures

  • % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg [Time frame: 1 month]
Secondary outcome measures (4)
  • % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg [Time frame: 1 month]
  • CD34+ cells and the average number of collections [Time frame: 1 month]
  • Adverse Rvents (AEs) [Time frame: 1 month]
  • % of patients who use Plerixafor [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • 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.
  • 5\. Subjects must be able to understand the protocol and sign the informed consent.

Exclusion criteria

  • 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%.
  • 5\. Patients with active infection.
  • 6\. Previously received hematopoietic stem cell mobilization.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 16 centers
  • Dongyang People's Hospital — Dongyang
  • The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
  • Tongde Hospital of Zhejiang Province — Hangzhou
  • Huzhou central hospital — Huzhou
  • The First Hospital of Jiaxing — Jiaxing
  • Jinhua Municipal Central Hospital — Jinhua
  • Jinhua People's Hospital — Jinhua
  • Lishui Central Hospital — Lishui
  • … and 8 more centers

Identifiers

NCT: NCT06520176 · 2024-060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗