Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520176
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 21 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 5106kg after a single collection the proportion of patients who cumulatively achieve the target collection value CD34 cells 2106kg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None