A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes Who Discontinued Treatment With Luspatercept or Epoetin Alfa and the COMMANDS Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Participant treatment patterns: Reason for treatment administration
研究概览
简要总结
This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant was enrolled in and discontinued the COMMANDS trial.
- •Participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the COMMANDS trial.
- •Participant Patient provides informed consent (only where applicable or required by local regulations).
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Luspatercept
Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536).
干预措施: Luspatercept (Drug)
Epoetin alfa
Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536).
干预措施: Epoetin Alfa (Drug)
结局指标
主要结局
Participant treatment patterns: Reason for treatment administration
时间窗: Up to 24 months
Participant treatment patterns: Time to next line of therapy (LoT)
时间窗: Up to 24 months
Participant treatment patterns: Reason for treatment discontinuation
时间窗: Up to 24 months
Participant treatment patterns: Type of concomitant medications received
时间窗: Up to 24 months
Participant treatment patterns: Type of treatment received
时间窗: Up to 24 months
Participant treatment patterns: Duration of treatment received
时间窗: Up to 24 months
Participant treatment patterns: Dosage of treatment received
时间窗: Up to 24 months
Participant treatment patterns: Dosing route of treatment administration
时间窗: Up to 24 months
Participant treatment patterns: Start and end dates of concomitant medications received
时间窗: Up to 24 months
次要结局
- Participant clinical characteristics(Up to 24 months)
- Participant clinical outcomes: Date and primary cause of death(Up to 24 months)
- Participant clinical outcomes: Number of units of red blood cell transfusions received(Up to 24 months)
- Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category(Up to 24 months)
- Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018(Up to 24 months)
- Participant clinical outcomes: Blood test results(Up to 24 months)
- Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status(Up to 24 months)
- Number of participants that progressed to high-risk myelodysplastic syndromes (MDS)(Up to 24 months)
- Participant clinical outcomes: Participant survival status(Up to 24 months)