NCT07075406已完成不适用
Real-world Utilization Patterns, Clinical Outcomes, and HCRU in Lower-risk MDS Patients Treated With Luspatercept: A Multinational Medical Record Review Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年11月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Participant baseline demographics
研究概览
简要总结
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
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
- •Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis
- •IPSS risk level: low, intermediate-1 (level-1 risk)
- •IPSS-R risk level: very low, low, intermediate
- •Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest
- •US: after April 2020
- •Germany: after June 2020
- •Spain: after June 2020
- •France: after June 202
- •Canada: after February 2021
- •The participant has a potential follow-up of at least 6 months from the index date (except death)
- •The participant is aged 18 years or older at the index date
- •The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)
排除标准
- •Received luspatercept as part of a clinical trial
- •The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
- •The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
- •The participant has participated in clinical trials for specific treatments related to treatment of MDS
研究组 & 干预措施
Participants receiving luspatercept treatment
干预措施: Luspatercept (Drug)
结局指标
主要结局
Participant baseline demographics
时间窗: Baseline
Participant baseline clinical characteristics
时间窗: Baseline
Participant treatment history
时间窗: Baseline
次要结局
- Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities(Up to 12 months)
- Systemic therapy agent or combination of agents received by participants(Up to 12 months)
- Treating clinicians' rationale for prescribing treatment(s)(Up to 12 months)
- Time to treatment discontinuation(Up to 12 months)
- Duration of treatment(Up to 12 months)
- Reason(s) for treatment discontinuation(Up to 12 months)
- Treatment dosing characteristics(Up to 12 months)
- Sequence of treatments prescribed to participants(Up to 12 months)
- Number and proportion of participants who received stem-cell transplant(Up to 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United StatesNCT06851065Bristol-Myers Squibb418
已完成
不适用
Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in ChinaNCT07073690Bristol-Myers Squibb88
进行中（未招募）
2 期
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.Beta-thalassemiaNCT05567458Bristol-Myers Squibb94
进行中（未招募）
3 期
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome ParticipantsMyelodysplastic SyndromesNCT06045689Bristol-Myers Squibb106
进行中（未招募）
不适用
To Evaluate Long- Term Safety and Efficacy of LuspaterceptNCT06875219Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia350