Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Progression-free survival
研究概览
简要总结
Research question: Is KRd therapy effective and safe in the real-world Asian patients?
Primay objective: To evaluate the effectiveness of KRd in RRMM patients
Secondary objectives:
To evaluate the effectiveness of investigational treatment strategy by
- PFS difference according to the high-risk disease subgroups and previous treatment
- OS
- Overall response rate and clinical benefit rate
- Duration of response To evaluate the safety and tolerability of KRd in RRMM patients
详细描述
Key study variables:
Demographic data, ISS, R-ISS, cytogenetic abnormalities on FISH and G-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, MM-related symptoms, whether or not M protein has increased twice or more in 2-3 months at the time of KRd commencement, response to KRd therapy, duration of KRd treatment, adverse events during KRd therapy, disease progression and progression date, survival, and censored date or day of death
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 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
Relapsed and/or refractory multiple myeloma
Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
干预措施: Carfilzomib (Drug)
Relapsed and/or refractory multiple myeloma
Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
干预措施: Lenalidomide (Drug)
Relapsed and/or refractory multiple myeloma
Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to 54 months
the time from the first date of KRd to the date of disease progression or death or censored date
次要结局
- Overall survival(up to 54 months)
- Overall response rate, clinical benefit rate(up to 54 months)
- Duration of response(up to 54 months)
- Toxicity profile(up to 2 years)
研究者
Sung-Hyun Kim
Professor
Dong-A University Hospital