Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
NCT ID: NCT06520176
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
99 participants
INTERVENTIONAL
2024-08-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Etoposide
Day 1\~Day 2: 75mg/m\^2
Cytarabine
Day 1\~Day 2: 200g/m\^2, q12h
Pegfilgrastim
Day 6: 6mg
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.
CG regimen group
33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
Cyclophosphamide
Day 1\~Day 2: 1～2g/m\^2
G-CSF
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Interventions
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Etoposide
Day 1\~Day 2: 75mg/m\^2
Cytarabine
Day 1\~Day 2: 200g/m\^2, q12h
Pegfilgrastim
Day 6: 6mg
Cyclophosphamide
Day 1\~Day 2: 1～2g/m\^2
G-CSF
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
OTHER
The Central Hospital of Lishui City
OTHER
Jinhua People's Hospital
OTHER
Shaoxing People's Hospital
OTHER
Shaoxing Second Hospital
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Taizhou Hospital
OTHER
Dongyang People's Hospital
OTHER
Affiliated Hospital of Jiaxing University
OTHER
Huizhou Municipal Central Hospital
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Jinhua Municipal Central Hospital
OTHER
The Affiliated People's Hospital of Ningbo University
OTHER_GOV
Responsible Party
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Principal Investigators
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Ying Lu
Role: PRINCIPAL_INVESTIGATOR
The Affiliated People's Hospital of Ningbo University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-060
Identifier Type: -
Identifier Source: org_study_id
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