First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)
2026年8月6日 更新者：Bristol-Myers Squibb
A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions
This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care.
The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes.
Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.
研究概览
研究类型
观察性的
注册 (估计的)
190
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：First line of the email MUST contain NCT # and Site #.
研究联系人备份
- 姓名：BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- 电话号码：855-907-3286
- 邮箱：Clinical.Trials@bms.com
学习地点
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Mainz、德国
- Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
描述
Inclusion Criteria:
- Males and females ≥18 years of age at enrollment.
- Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease.
- Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation.
- First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation
- Provision of written informed consent.
Exclusion Criteria:
- Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).
- Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol).
Patients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.
• Concurrent malignancy requiring treatment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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First-Line Luspatercept
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
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根据产品标签
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
大体时间：Up to Week 24
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Up to Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
大体时间：Up to Week 48
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Up to Week 48
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Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
大体时间：Up to Week 48
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Up to Week 48
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Mean change from baseline in hemoglobin concentration
大体时间：Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Hemoglobin concentration (g/dL) measured during routine clinical practice.
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline
大体时间：Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Hemoglobin concentration (g/dL) measured during routine clinical practice.
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Percentage of participants achieving >50% reduction in transfusion burden compared with baseline
大体时间：Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Time from first luspatercept administration to first on-treatment red blood cell transfusion.
大体时间：Up to 2-years
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Up to 2-years
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Time to red blood cell transfusion independence for at least 8 consecutive weeks
大体时间：Up to Week 24
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Up to Week 24
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.
大体时间：Up to 2-years
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Up to 2-years
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 84 consecutive days.
大体时间：Up to 2-years
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Up to 2-years
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 112 consecutive days.
大体时间：Up to 2-years
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Up to 2-years
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Percentage of participants achieving hematologic improvement-erythroid response according to International Working Group (IWG) 2006 criteria
大体时间：Up to Week 48
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Hematologic improvement-erythroid (HI-E) response is defined as an increase in hemoglobin of at least 1.5 g/dL and/or a reduction of at least 4 red blood cell transfusions during an 8-week period compared with the 8 weeks before treatment, sustained over any consecutive 56-day period
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Up to Week 48
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Number of participants with adverse events
大体时间：Up to 2-years
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Up to 2-years
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Change from baseline in health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
大体时间：Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Change from baseline in health-related quality of life assessed by Quality of Life in Myelodysplasia Scale (QUALMS)
大体时间：Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Bristol-Myers Squibb、Bristol-Myers Squibb
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月24日
初级完成 (估计的)
2030年8月31日
研究完成 (估计的)
2030年8月31日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年8月6日
首次发布 (实际的)
2026年8月7日
研究记录更新
最后更新发布 (实际的)
2026年8月7日
上次提交的符合 QC 标准的更新
2026年8月6日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CA056-1175
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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