Actively Recruiting
Study of Etoposide, Cytarabine with Pegfilgrastim vs Cyclophosphamide with G-CSF for Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma
Led by The Affiliated People's Hospital of Ningbo University · Updated on 2024-07-25
99
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Affiliated People's Hospital of Ningbo University
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, randomized, two-arm, multicenter study to evaluate the safety and effectiveness of two drug combinations for mobilizing hematopoietic stem cells in patients newly diagnosed with multiple myeloma. The study aims to compare the combination of etoposide, cytarabine, and Pegfilgrastim (EAP regimen) against the combination of cyclophosphamide and G-CSF (GC regimen). The goal is to observe and compare the mobilization outcomes and any adverse reactions in these patients. A total of 99 patients with newly diagnosed multiple myeloma will be randomly assigned in a 2:1 ratio to receive either the EAP regimen or the CG regimen. The EAP group will receive etoposide and cytarabine on days 1 and 2, followed by Pegfilgrastim on day 6. The CG group will receive cyclophosphamide on days 1 and 2, with G-CSF injections starting on day 6 and continuing during mobilization. Researchers will monitor the collection of CD34+ stem cells, the need for additional medication Plerixafor, and record any blood-related or other side effects. Participants will be closely monitored during the mobilization period to measure the number of stem cells collected, the number of collections needed, and any adverse events. The primary outcome is the percentage of patients who collect at least 510^6 CD34+ cells/kg within one month. Secondary outcomes include collection of at least 210^6 CD34+ cells/kg, total CD34+ cells collected, average collections, safety, and Plerixafor use. The study will last for approximately one month of active monitoring after treatment, with data collected on efficacy and safety throughout this period.
CONDITIONS
Brief Title
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with multiple myeloma
- Eligible for autologous stem cell transplantation (ASCT)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Able to understand the study and provide informed consent
You will not qualify if you...
- Cardiac function class II or higher, or cardiac ejection fraction less than 40%
- Serum direct bilirubin greater than twice the upper limit of normal
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than three times the upper limit of normal
- Serum creatinine clearance rate 30% or less
- Active infection at the time of screening
- Previous hematopoietic stem cell mobilization prior to this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive either the EAP regimen (etoposide, cytarabine, and pegfilgrastim) or the CG regimen (cyclophosphamide and G-CSF) to mobilize hematopoietic stem cells.
Several visits during the mobilization period for drug administration and stem cell collection
Trial Site Locations
Total: 16 locations
1
Dongyang People's Hospital
Dongyang, Zhejiang, China
Actively Recruiting
2
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
3
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Actively Recruiting
4
Huzhou central hospital
Huzhou, Zhejiang, China
Actively Recruiting
5
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Actively Recruiting
6
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Actively Recruiting
7
Jinhua People's Hospital
Jinhua, Zhejiang, China
Actively Recruiting
8
Lishui Central Hospital
Lishui, Zhejiang, China
Actively Recruiting
9
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
10
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
11
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Actively Recruiting
12
Shaoxing Second Hospital
Shaoxing, Zhejiang, China
Actively Recruiting
13
Taizhou Central Hospital
Taizhou, Zhejiang, China
Actively Recruiting
14
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
15
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
16
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Lu
P
Peipei Ye
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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