NCT06520176

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: The Affiliated People's Hospital of Ningbo University · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells \>5×10\^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells \>2×10\^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.

Conditions

• Multiple Myeloma
• Hematopoietic Stem Cell Mobilization

Interventions

Type	Name	Description
DRUG	Etoposide	Day 1\~Day 2: 75mg/m\^2
DRUG	Cytarabine	Day 1\~Day 2: 200g/m\^2, q12h
DRUG	Pegfilgrastim	Day 6: 6mg
DRUG	Cyclophosphamide	Day 1\~Day 2: 1～2g/m\^2
DRUG	G-CSF	Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
DRUG	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-25
• Last updated: 2024-07-25

Locations

16 sites across 1 country: China