NCT06952478招募中3 期
A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Celltrion
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- PK equivalence of CT-P44 and Darzalex Faspro
研究概览
简要总结
This study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CT-P44
Experimental
CT-P44 1800mg SC (subcutaneous)
干预措施: CT-P44(Daratumumab) (Biological)
Darzalex Faspro
Active Comparator
Darzalex Faspro 1800mg SC (subcutaneous)
干预措施: Darzalex Faspro(Daratumumab) (Biological)
结局指标
主要结局
PK equivalence of CT-P44 and Darzalex Faspro
时间窗: Week 0 ~ Week 24
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Therapeutic equivalence of CT-P44 and Darzalex Faspro
时间窗: Week 0 ~ Week 24
Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
次要结局
未报告次要终点
研究者
研究点 (1)
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