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

Phase 3

Recruiting

• Conditions: Multiple Myeloma; Hematopoietic Stem Cell Mobilization
• Interventions: Drug: Etoposide; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Pegfilgrastim; Drug: G-CSF

• Registration Number: NCT06520176
• Lead Sponsor: The Affiliated People's Hospital of Ningbo University

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 ...

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 cell...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-20
• Last Update Submitted: 2024-07-20
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Study Start: 2024-08
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EAP regimen group	Etoposide	66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
EAP regimen group	Cytarabine	66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
EAP regimen group	Pegfilgrastim	66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
EAP regimen group	G-CSF	66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
CG regimen group	Cyclophosphamide	33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
CG regimen group	G-CSF	33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.

Primary Outcome Measures

Name	Time	Method
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg	1 month	Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection

Secondary Outcome Measures

Name	Time	Method
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg	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.
CD34+ cells and the average number of collections	1 month	Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
Adverse Rvents (AEs)	1 month	Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
% of patients who use Plerixafor	1 month	Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.

Trial Locations

Locations (16)

Dongyang People's Hospital; 🇨🇳 Dongyang, Zhejiang, China

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The First Hospital of Jiaxing; 🇨🇳 Jiaxing, Zhejiang, China

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, Zhejiang, China

Huzhou central hospital; 🇨🇳 Huzhou, Zhejiang, China

Tongde Hospital of Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China

Lishui Central Hospital; 🇨🇳 Lishui, Zhejiang, China

Jinhua People's Hospital; 🇨🇳 Jinhua, Zhejiang, China

Shaoxing Second Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Taizhou Central Hospital; 🇨🇳 Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang, China

Shaoxing People's Hospital; 🇨🇳 Shaoxing, Zhejiang, China

The Affiliated People's Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province; 🇨🇳 Taizhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China