Velcade - Regulatory Post Marketing Surveillance (PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,121
- 主要终点
- The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
研究概览
简要总结
After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).
详细描述
After the KFDA approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade). We will collect the response rate according to the EMBT (European Group for Blood and Marrow Transplant; a non-profit organization based in the Netherlands that promotes the transplantation of haemopoietic stem cells from all donor sources and donor types and related basic and clinical research, education, standardization, quality control, and accreditation for transplant procedures) or IMWG (the International Myeloma Working Group) criteria and the adverse events to assess the efficacy and safety. Observational Study - No investigational drug administered
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma
排除标准
- •Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity
- •Patients with severe hepatic impairment
- •Pregnant women
研究组 & 干预措施
001
bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days
干预措施: bortezomib (Drug)
结局指标
主要结局
The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
时间窗: every cycles or every 3 weeks
次要结局
- The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.(every cycle or every 3 weeks and end of treatment)