Status:
RECRUITING
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Lead Sponsor:
The Affiliated People's Hospital of Ningbo University
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Multiple Myeloma
Hematopoietic Stem Cell Mobilization
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 m...
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 hemato...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06520176
Start Date
August 1 2024
End Date
December 1 2026
Last Update
July 25 2024
Active Locations (16)
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1
Dongyang People's Hospital
Dongyang, Zhejiang, China
2
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
3
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
4
Huzhou central hospital
Huzhou, Zhejiang, China