A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 16
- 主要终点
- % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed as multiple myeloma.
- •Indication for ASCT.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0~
- •Life expectancy ≥ 3 months.
- •Subjects must be able to understand the protocol and sign the informed consent.
排除标准
- •Cardiac function class II or higher or cardiac ejection fraction <40%.
- •Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN).
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN.
- •Serum creatinine clearance rate≤30%.
- •Patients with active infection.
- •Previously received hematopoietic stem cell mobilization.
研究组 & 干预措施
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: Cytarabine (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: Etoposide (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: Pegfilgrastim (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: G-CSF (Drug)
CG regimen group
33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
干预措施: Cyclophosphamide (Drug)
CG regimen group
33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
干预措施: G-CSF (Drug)
结局指标
主要结局
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
时间窗: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection
次要结局
- % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg(1 month)
- CD34+ cells and the average number of collections(1 month)
- Adverse Rvents (AEs)(1 month)
- % of patients who use Plerixafor(1 month)