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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
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.
Dongyang People's Hospital
Dongyang, Zhejiang, China
RECRUITINGThe First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
RECRUITINGHuzhou central hospital
Huzhou, Zhejiang, China
RECRUITINGThe First Hospital of Jiaxing
Jiaxing, Zhejiang, China
RECRUITINGJinhua Municipal Central Hospital
Jinhua, Zhejiang, China
RECRUITINGJinhua People's Hospital
Jinhua, Zhejiang, China
RECRUITINGLishui Central Hospital
Lishui, Zhejiang, China
RECRUITINGNingbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
RECRUITINGThe Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
RECRUITING...and 6 more locations
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection
Time frame: 1 month
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
Comparison of the cumulative proportion of patients who achieve the target collection value (CD34+ cells ≥2×10\^6/kg) between the EAP and CG regimens; the proportion of patients who achieve the ideal collection value.
Time frame: 1 month
CD34+ cells and the average number of collections
Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
Time frame: 1 month
Adverse Rvents (AEs)
Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
Time frame: 1 month
% of patients who use Plerixafor
Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.
Time frame: 1 month
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