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NCT Number: NCT06520176

Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dongyang People's Hospital, Dongyang, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etoposide

Drug

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

Other names: VP-16

Cytarabine

Drug

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

Other names: Ara-C

pegfilgrastim

Drug

Day 6: 6mg

Other names: PEG-rhG-CSF

Cyclophosphamide

Drug

Day 1~Day 2: 1~2g/m^2

Other names: Cy

G-CSF

Drug

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

Other names: Granulocyte Colony Stimulating Factor

Primary outcomes

  1. % 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

Secondary outcomes

  1. % 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.

  2. 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.

  3. Adverse Rvents (AEs)

    Time frame: 1 month

    Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.

  4. % of patients who use Plerixafor

    Time frame: 1 month

    Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Affiliated People's Hospital of Ningbo University

Other Gov

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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