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.
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.
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%.
Parallel
Etoposide
DrugDay 1\~Day 2: 75mg/m\^2
Cytarabine
DrugDay 1\~Day 2: 200g/m\^2, q12h
Pegfilgrastim
DrugDay 6: 6mg
Cyclophosphamide
DrugDay 1\~Day 2: 1～2g/m\^2
G-CSF
DrugSubcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
G-CSF
DrugStarting 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.
% 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
% 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.
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.
Adverse Rvents (AEs)
Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
% of patients who use Plerixafor
Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.
Click on the lead sponsor to view all of their trials.
The Affiliated People's Hospital of Ningbo University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Central Hospital of Lishui City
Collaborator
Jinhua People's Hospital
Collaborator
Shaoxing People's Hospital
Collaborator
Shaoxing Second Hospital
Collaborator
Zhejiang Provincial Tongde Hospital
Collaborator
Taizhou Hospital
Collaborator
Dongyang People's Hospital
Collaborator
Affiliated Hospital of Jiaxing University
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
Jinhua Municipal Central Hospital
Collaborator
