Trial Title:
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
NCT ID:
NCT06520176
Condition:
Multiple Myeloma
Hematopoietic Stem Cell Mobilization
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Cytarabine
Cyclophosphamide
Etoposide
Lenograstim
Conditions: Keywords:
Multiple Myeloma
Etoposide
Cytarabine
PEG-rhG-CSF
Hematopoietic Stem Cell Mobilization
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, randomized, two-arm, multicenter, exploratory study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Day 1~Day 2: 75mg/m^2
Arm group label:
EAP regimen group
Other name:
VP-16
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Day 1~Day 2: 200g/m^2, q12h
Arm group label:
EAP regimen group
Other name:
Ara-C
Intervention type:
Drug
Intervention name:
Pegfilgrastim
Description:
Day 6: 6mg
Arm group label:
EAP regimen group
Other name:
PEG-rhG-CSF
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Day 1~Day 2: 1～2g/m^2
Arm group label:
CG regimen group
Other name:
Cy
Intervention type:
Drug
Intervention name:
G-CSF
Description:
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Arm group label:
CG regimen group
Other name:
Granulocyte Colony Stimulating Factor
Intervention type:
Drug
Intervention name:
G-CSF
Description:
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.
Arm group label:
EAP regimen group
Other name:
Granulocyte Colony Stimulating Factor
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Patients newly diagnosed as multiple myeloma.
-
2. Indication for ASCT.
-
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
-
4. Life expectancy ≥ 3 months.
-
5. Subjects must be able to understand the protocol and sign the informed consent.
Exclusion Criteria:
-
1. Cardiac function class II or higher or cardiac ejection fraction <40%.
-
2. Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN).
-
3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN.
-
4. Serum creatinine clearance rate≤30%.
-
5. Patients with active infection.
-
6. Previously received hematopoietic stem cell mobilization.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongyang People's Hospital
Address:
City:
Dongyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Gongqiang Wu
Phone:
13757950788
Email:
Wugongqiang59@126.com
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin
Phone:
13507016779
Email:
jiej0503@163.com
Facility:
Name:
Tongde Hospital of Zhejiang Province
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Huifang Jiang
Phone:
13957182087
Email:
Jianghuifang501@163.com
Facility:
Name:
Huzhou central hospital
Address:
City:
Huzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihong Shou
Phone:
13587206019
Email:
SLH077@126.COM
Facility:
Name:
The First Hospital of Jiaxing
Address:
City:
Jiaxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zeng
Phone:
13957330440
Email:
zhwuhan@163.com
Facility:
Name:
Jinhua Municipal Central Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingcheng Zhang
Phone:
13958480529
Email:
zjc1983@126.com
Facility:
Name:
Jinhua People's Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Huang
Phone:
13566782316
Email:
huanglixiaoyu@126.com
Facility:
Name:
Lishui Central Hospital
Address:
City:
Lishui
Country:
China
Status:
Recruiting
Contact:
Last name:
Linjie Li
Phone:
13567615761
Email:
Lilinjie0394@163.com
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Le
Phone:
13566511755
Email:
nblejing@aliyun.com
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lu
Phone:
+86-13486090834
Email:
814871416@qq.com
Contact backup:
Last name:
Peipei Ye
Phone:
+86-13685832706
Email:
39612903@qq.com
Facility:
Name:
Shaoxing People's Hospital
Address:
City:
Shaoxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiying Feng
Phone:
13588570250
Email:
fengweiying1997@126.com
Facility:
Name:
Shaoxing Second Hospital
Address:
City:
Shaoxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiguo Zhu
Phone:
18767509030
Email:
yin990216@sina.com
Facility:
Name:
Taizhou Central Hospital
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sai Chen
Phone:
13575809591
Email:
chens7111@tzzxyy.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunyi Guo
Phone:
13515861286
Email:
guoqunyi@163.com
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Shujuan Zhou
Phone:
13738368586
Email:
Zhousj320@163.com
Facility:
Name:
The Second Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lin
Phone:
13705883857
Email:
wzly1974@hotmail.com
Start date:
August 2024
Completion date:
December 2026
Lead sponsor:
Agency:
The Affiliated People's Hospital of Ningbo University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
The Central Hospital of Lishui City
Agency class:
Other
Collaborator:
Agency:
Jinhua People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoxing People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoxing Second Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial Tongde Hospital
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital
Agency class:
Other
Collaborator:
Agency:
Dongyang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Jiaxing University
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Jinhua Municipal Central Hospital
Agency class:
Other
Source:
The Affiliated People's Hospital of Ningbo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06520176
