Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 62
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.
The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM.
Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).
详细描述
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.
Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).
The study has the following objectives:
Primary objective
- The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with RRMM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021
排除标准
- 未提供
结局指标
主要结局
Overall response rate (ORR)
时间窗: Throughout the study period. Approximately 3 years
The percentage of participants with the best overall confirmed response: partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). per International Myeloma Working Group (IMWG) uniform response criteria.
次要结局
- Progression free survival (PFS)(Throughout the study period. Approximately 3 years)
- Incidence of treatment-emergent adverse events (AEs)(Throughout the study period. Approximately 3 years)
- Time to response (TTR)(Throughout the study period. Approximately 3 years)
- Time to next treatment (TTNT).(Throughout the study period. Approximately 3 years)
- Incidence of ocular events(Throughout the study period. Approximately 3 years)
- Duration of response (DOR)(Throughout the study period. Approximately 3 years)
- Overall survival (OS)(Throughout the study period. Approximately 3 years)
- Second progression free survival (PFS2)(Throughout the study period. Approximately 3 years)