Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.
详细描述
This is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with MM.
The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions.
The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs).
All participants will be enrolled in a single observational group:
• Participants With MM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with MM.
- •Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label.
排除标准
- •Participants treated with ixazomib citrate outside of the locally approved label in South Korea.
- •Participants for which ixazomib citrate is contraindicated as per product label.
结局指标
主要结局
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Up to 6 months
次要结局
- Progression-free Survival (PFS)(From first administration of study drug to the date of disease progression or death due to any cause, whichever occurs first (up to 6 months))
- Overall Response Rate (ORR)(Up to 6 months)