A Retrospective Chart Review and a Prospective Study of the POmalidomide Plus LoW Dose Dexamethasone Efficacy in Relapsed/ ReFractory Multiple Myeloma Patients Under Real-Life Conditions,
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Effectiveness of Pom/LoDex in terms of median PFS
研究概览
简要总结
The importance of real-world evidence studies stems from the following considerations. The study population of a specific clinical trial needs to meet strict inclusion and exclusion criteria, which result in a population of participants that is not necessarily representative of the study population of interest treated in routine care. Furthermore, the outcomes of a clinical trial occur under controlled conditions that do not necessarily reflect the routine healthcare practice. This is especially true among patient populations with challenging to treat disease such as in MM, where personalized therapeutic approaches are commonly considered taking into consideration the patients' age and associated comorbidities, among other factors. In addition, observational studies, due to their non-interventional nature, often show increased degree of heterogeneity across the enrolled patient populations compared to clinical studies, thus aiding generalizability of the results.
In light of the above and due to the scarcity of evidence regarding the outcomes for patients with RRMM receiving Pom/LoDex in routine clinical practice, this retrospective chart review and prospective observational study aims to assess the PFS and response to treatment as well as to obtain real-world evidence on the utilization patterns and management strategy of Pom/LoDex in routine clinical care settings in Greece.
This is a non-interventional, multicenter, single-country, retrospective chart review and prospective cohort study which will include a representative sample of patients with RRMM who have been initiated on Pom/LoDex between 01 January 2016 and 28 February 2019 in the third line and beyond treatment setting under routine care conditions in Greece.
The study will be carried out by hospital-based hematology specialists practicing in geographically diverse locations throughout Greece and will be conducted under real-world conditions of daily clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study:
- •Prior malignancy (within the 3 years preceding initial diagnosis of MM).
- •Concurrent administration of anti-cancer regimens for malignancies other than MM.
- •Subjects currently participating or who have participated, during the treatment phase, in any investigational program with interventions outside of routine clinical practice.
结局指标
主要结局
Effectiveness of Pom/LoDex in terms of median PFS
时间窗: median time from start of Pom/LoDex treatment to disease progression or death, through study completion and maximum 50 months
To evaluate the effectiveness of Pom/LoDex in terms of median PFS, in eligible patients with RRMM in a real world setting in Greece.
次要结局
- Response to Pom/LoDex treatment in terms of ORR(from start of Pom/LoDex until achievement of PR or better, through study completion and maximum 50 months)
- Response to Pom/LoDex treatment in terms of CBR(from start of Pom/LoDex until achievement of MR or better, through study completion and maximum 50 months)
- DoR among the RRMM study population who achieved at least partial response (PR)(median from start of Pom/LoDex to first disease progrestion or death (DoR), through study completion and maximum 50 months)
- Time to progression(median time from start of Pom/LoDex until disease progression or death, through study completion and maximum 50 months)
- Response to Pom/LoDex treatment in terms of DCR(from start of Pom/LoDex until achievement of SD or better, through study completion and maximum 50 months)
- TTR among the RRMM study population who achieved at least partial response (PR)(median from start of Pom/LoDex to first documented response (TTR), through study completion and maximum 50 months)
- Real-world utilization patterns of Pom/LoDex in the RRMM study population(no time frame - only proportion of patients in 12 month follow-up)
- 12-month PFS rate(time from start of Pom/LoDex until 12 months)