NCT05007652已完成2 期
A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 21
- 主要终点
- Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
研究概览
简要总结
To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic stem cells into the peripheral blood in patients with multiple myeloma.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for the multiple myeloma cohort
- •Patients with histologically or pathologically diagnosed multiple myeloma
- •Patients who achieved CR, sCR, VGPR, and PR with induction therapy Criteria for the malignant lymphoma cohort
- •Patients with histologically or pathologically diagnosed malignant lymphoma
- •First or second CR or PR Multiple myeloma cohort, malignant lymphoma cohort common criteria
- •Patients aged 20 to 75 years or younger at the time of informed consent
排除标准
- •Those who received allogeneic hematopoietic stem cell transplantation (Allo-SCT), autologous hematopoietic stem cell transplantation (ASCT), or CAR-T therapy
- •Patients who have developed adverse events leading to discontinuation of hematopoietic stem-cell collection due to administration of granulocyte colony-stimulating factor (G-CSF) or apheresis
- •Patients who have not been able to collect adequate amounts of hematopoietic stem cells with G-CSF or plerixafor administration
- •Patients with hypersensitivity to G-CSF or plerixafor
- •Patients with ECOG Performance status (PSs) of 2 or greater.
- •Patients whose cardiac or pulmonary conditions were judged to be inappropriate for apheresis or ASCT.
- •Pregnant or breastfeeding female patients
研究组 & 干预措施
multiple myeloma cohort (KRN125)
Experimental
干预措施: KRN125(pegfilgrastim), PLR001(plerixafor) (Drug)
multiple myeloma cohort (KRN8601)
Active Comparator
干预措施: KRN8601(filgrastim), PLR001(plerixafor) (Drug)
malignant lymphoma cohort
Experimental
干预措施: KRN125(pegfilgrastim), PLR001(plerixafor) (Drug)
结局指标
主要结局
Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
时间窗: Day 5, 6, 7
次要结局
- Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.(Day 1, 4, 5, 6, 7)
研究者
研究点 (21)
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