Study Comparing Etoposide, Cytarabine, and Pegfilgrastim vs Cyclophosphamide and G-CSF for Stem Cell Mobilization in New Multiple Myeloma Patients

What this Trial Is About

Researchers are conducting a prospective, randomized, two-arm, multicenter study to evaluate the safety and effectiveness of two drug combinations for mobilizing hematopoietic stem cells in patients newly diagnosed with multiple myeloma. The study aims to compare the combination of etoposide, cytarabine, and Pegfilgrastim EAP regimen against the combination of cyclophosphamide and G-CSF GC regimen. The goal is to observe and compare the mobilization outcomes and any adverse reactions in these patients. A total of 99 patients with newly diagnosed multiple myeloma will be randomly assigned in a 21 ratio to receive either the EAP regimen or the CG regimen. The EAP group will receive etoposide and cytarabine on days 1 and 2, followed by Pegfilgrastim on day 6. The CG group will receive cyclophosphamide on days 1 and 2, with G-CSF injections starting on day 6 and continuing during mobilization. Researchers will monitor the collection of CD34 stem cells, the need for additional medication Plerixafor, and record any blood-related or other side effects. Participants will be closely monitored during the mobilization period to measure the number of stem cells collected, the number of collections needed, and any adverse events. The primary outcome is the percentage of patients who collect at least 5106 CD34 cellskg within one month. Secondary outcomes include collection of at least 2106 CD34 cellskg, total CD34 cells collected, average collections, safety, and Plerixafor use. The study will last for approximately one month of active monitoring after treatment, with data collected on efficacy and safety throughout this period.

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