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

NCT06520176 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-060
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

Multiple Myeloma; Etoposide; Cytarabine; PEG-rhG-CSF; Hematopoietic Stem Cell Mobilization

Outcome Measures

Primary Outcomes (1)

• % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg

  Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection

  1 month

Secondary Outcomes (4)

• % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg

  1 month

• CD34+ cells and the average number of collections

  1 month

• Adverse Rvents (AEs)

  1 month

• % of patients who use Plerixafor

  1 month

Study Arms (2)

EAP regimen group

EXPERIMENTAL

66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.

Drug: Etoposide; Drug: Cytarabine; Drug: Pegfilgrastim; Drug: G-CSF

CG regimen group

ACTIVE COMPARATOR

33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.

Drug: Cyclophosphamide; Drug: G-CSF

Interventions

Etoposide DRUG

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

Also known as: VP-16

EAP regimen group

Cytarabine DRUG

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

Also known as: Ara-C

EAP regimen group

Pegfilgrastim DRUG

Day 6: 6mg

Also known as: PEG-rhG-CSF

EAP regimen group

Cyclophosphamide DRUG

Day 1\~Day 2: 1～2g/m\^2

Also known as: Cy

CG regimen group

G-CSF DRUG

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

Also known as: Granulocyte Colony Stimulating Factor

CG regimen group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients newly diagnosed as multiple myeloma.
• \. Indication for ASCT.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
• \. Life expectancy ≥ 3 months.
• \. Subjects must be able to understand the protocol and sign the informed consent.

You may not qualify if:

• \. Cardiac function class II or higher or cardiac ejection fraction \<40%.
• \. Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN).
• \. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN.
• \. Serum creatinine clearance rate≤30%.
• \. Patients with active infection.
• \. Previously received hematopoietic stem cell mobilization.

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University: lead
• 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

Study Sites (16)

Dongyang People's Hospital

Dongyang, Zhejiang, China

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

RECRUITING

Huzhou central hospital

Huzhou, Zhejiang, China

RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

RECRUITING

Jinhua People's Hospital

Jinhua, Zhejiang, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

RECRUITING

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

RECRUITING

Taizhou Central Hospital

Taizhou, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Etoposide; Cytarabine; pegfilgrastim; pegylated granulocyte colony-stimulating factor; Cyclophosphamide; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ying Lu

  The Affiliated People's Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Lu

CONTACT

+86-13486090834; 814871416@qq.com

Peipei Ye

CONTACT

+86-13685832706; 39612903@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, two-arm, multicenter, exploratory study

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

CN (16)