A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Safety Assessment
研究概览
简要总结
This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No control groups were considered in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
详细描述
This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. Data were gathered in two booklets, containing information on sixteen injections, which were filled by the designated physician.
Exposure to Alvocade® in this study was defined as administration of bortezomib (Alvocade®, NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16 injections).
The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
This study was single arm and the sample size of this study was 59 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma were included in the study.
排除标准
- •There were no exclusion criteria for this study.
研究组 & 干预措施
NanoAlvand Bortezomib
1.3 mg/m2 Bortezomib, IV infusion
干预措施: Bortezomib (Drug)
结局指标
主要结局
Safety Assessment
时间窗: up to 6 months
Safety assessment, including the incidence of AEs. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
次要结局
- Effectiveness Assessment(up to 6 months)