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
The Affiliated People's Hospital of Ningbo University
99 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- \. 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.
Exclusion Criteria6
- \. 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.
Interventions
Day 1\~Day 2: 75mg/m\^2
Day 1\~Day 2: 200g/m\^2, q12h
Day 6: 6mg
Day 1\~Day 2: 1～2g/m\^2
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
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)
View Full Details on ClinicalTrials.gov
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NCT06520176