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RECRUITINGPhase 3INTERVENTIONAL

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

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: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (16)

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