A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- percentage of successful mobilization
研究概览
简要总结
This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma.
详细描述
Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10^6/kg CD34+ cells in three or fewer apheresis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
- •Patients who had achieved at least partial response (PR);
- •Patients who were eligible for autologous peripheral blood stem cell transplantation
- •Age≥18 and≤65 years;
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Patients who have an estimated life expectancy of more than three months
- •Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose.
- •Patients must be able and willing to give written informed consent prior to any study-related procedures
排除标准
- •Patients who had previously attempted hematopoietic stem cell mobilization;
- •Patients who had undergone previous bone marrow transplantation;
- •Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ;
- •Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, left ventricular ejection fraction (EF)<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation;
- •Patients with uncontrolled pulmonary infection;
- •Patients who had any of the following laboratory indicators:
- •White blood cell count(WBC)<2.5×109/L；
- •Absolute neutrophil count(ANC)<1.5×109/L；
- •Platelets count(PLT)<80×109/L；
- •Creatinine > 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
- •AST/ALT/Total bilirubin > 2.5 X ULN；
- •Patients who have received any of the following treatments:
- •Patients who had been treated with more than 4 cycles of lenalidomide or received lenalidomide within 4 weeks prior to hematopoietic stem cell mobilization chemotherapy.
- •Patients who previously been treated with fludarabine or melphalan;
- •Patients who plan to receive radiation within 30 days after transplantation
- •Patients who had received radiation therapy in the pelvis
- •Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
- •Patients who are pregnant or breastfeeding
- •Patients who are participating in other clinical studies or the interval of the last dose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5 half-lives of the study drug);
- •Patients with other conditions unsuitable for this study according to the investigator's judgment.
研究组 & 干预措施
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
干预措施: Etoposide (Drug)
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
干预措施: Mecapegfilgrastim, day 2 (Drug)
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
干预措施: Etoposide (Drug)
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
干预措施: Mecapegfilgrastim, day 5 (Drug)
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
干预措施: Cyclophosphamide (Drug)
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
干预措施: Mecapegfilgrastim, day 2 (Drug)
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
干预措施: Cyclophosphamide (Drug)
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
干预措施: Mecapegfilgrastim, day 5 (Drug)
结局指标
主要结局
percentage of successful mobilization
时间窗: up to 28 days since the last subject were given mecapegfilgrastim
The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.
次要结局
- the number of leukaphereses(up to 28 days since the last subject were given mecapegfilgrastim)
- Incidence of febrile neutropenia (FN)(up to 28 days since the last subject were given mecapegfilgrastim)
- times to neutrophil and platelet engraftment(up to 1 year post-transplantation)
- the number of the total CD34+ cells(up to 28 days since the last subject were given mecapegfilgrastim)