A Phase 2, Multi-center, Single-arm Study of TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 2 Prior Lines of Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 18
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.
详细描述
A total of 82 subjects with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of treatment will be enrolled in this study. Prior lines of treatment must include a proteasome inhibitor (PI) and an immunomodulator (IMiD). All subjects will receive TJ202 and dexamethasone (DEX) in the study. The treatment will continue until endpoint events such as intolerance or progressive disease (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
TJ202
干预措施: TJ202 and Dexamethasone (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: end of study [ Time Frame: Approximately up to 2 years ]
defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
次要结局
- Time to response (TTR)(end of study [ Time Frame: Approximately up to 2 years ])
- Time to progression (TTP)(end of study [ Time Frame: Approximately up to 2 years ])
- Duration of response (DOR)(end of study [ Time Frame: Approximately up to 2 years ])
- Clinical benefit rate (CBR)(end of study [ Time Frame: Approximately up to 2 years ])
- Progression-free survival (PFS)(end of study [ Time Frame: Approximately up to 2 years ])
- Overall survival (OS)(end of study [ Time Frame: Approximately up to 2 years ])