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

NCT06520176 Phase 3 RECRUITING

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.

Details

Lead sponsor	The Affiliated People's Hospital of Ningbo University
Phase	Phase 3
Status	RECRUITING
Enrolment	99
Start date	2024-08
Completion	2026-12

Conditions

• Multiple Myeloma
• Hematopoietic Stem Cell Mobilization

Interventions

• Etoposide
• Cytarabine
• Pegfilgrastim
• Cyclophosphamide
• G-CSF
• G-CSF

Primary outcomes

• % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg — 1 month
  Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection

Countries

China