First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)
6 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
190
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: First line of the email MUST contain NCT # and Site #.
Copia de seguridad de contactos de estudio
- Nombre: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Número de teléfono: 855-907-3286
- Correo electrónico: Clinical.Trials@bms.com
Ubicaciones de estudio
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Mainz, Alemania
- Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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Según etiqueta del producto
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Periodo de tiempo: Up to Week 24
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Up to Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Periodo de tiempo: 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
Periodo de tiempo: Up to Week 48
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Up to Week 48
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Mean change from baseline in hemoglobin concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de agosto de 2026
Finalización primaria (Estimado)
31 de agosto de 2030
Finalización del estudio (Estimado)
31 de agosto de 2030
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2026
Publicado por primera vez (Actual)
7 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CA056-1175
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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