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

July 20, 2024 updated by: The Affiliated People's Hospital of Ningbo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Dongyang, Zhejiang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
      • Huzhou, Zhejiang, China
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
      • Jiaxing, Zhejiang, China
        • Recruiting
        • The First hospital of Jiaxing
        • Contact:
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua People's Hospital
        • Contact:
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui Central Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
        • Contact:
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing Second Hospital
        • Contact:
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
Drug: Etoposide
Day 1~Day 2: 75mg/m^2
Other Names:
  • VP-16
Drug: Cytarabine
Day 1~Day 2: 200g/m^2, q12h
Other Names:
  • Ara-C
Drug: Pegfilgrastim
Day 6: 6mg
Other Names:
  • PEG-rhG-CSF
Drug: G-CSF
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Other Names:
  • Granulocyte Colony Stimulating Factor
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.
Other Names:
  • Granulocyte Colony Stimulating Factor
Active Comparator: CG regimen group
33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
Drug: G-CSF
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Other Names:
  • Granulocyte Colony Stimulating Factor
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.
Other Names:
  • Granulocyte Colony Stimulating Factor
Drug: Cyclophosphamide
Day 1~Day 2: 1～2g/m^2
Other Names:
  • Cy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Time Frame: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
Time Frame: 1 month
Comparison of the cumulative proportion of patients who achieve the target collection value (CD34+ cells ≥2×10^6/kg) between the EAP and CG regimens; the proportion of patients who achieve the ideal collection value.
1 month
CD34+ cells and the average number of collections
Time Frame: 1 month
Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
1 month
Adverse Rvents (AEs)
Time Frame: 1 month
Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
1 month
% of patients who use Plerixafor
Time Frame: 1 month
Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated People's Hospital of Ningbo University

Collaborators

Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Zhejiang University
Jinhua People's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Jinhua Municipal Central Hospital
The Central Hospital of Lishui City
First Affiliated Hospital of Wenzhou Medical University
Shaoxing People's Hospital
Shaoxing Second Hospital
Huizhou Municipal Central Hospital
Taizhou Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Zhejiang Provincial Tongde Hospital
Dongyang People's Hospital
Affiliated Hospital of Jiaxing University

Investigators

  • Principal Investigator: Ying Lu, The Affiliated People's Hospital of Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

July 20, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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