About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- Etoposide
- Cytarabine
- Pegfilgrastim
- Cyclophosphamide
- G-CSF
- G-CSF
Treatment groups
Sponsors and collaborators
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