- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01524445
Retrospective Survey of Re-treatment With Bortezomib
11 de junio de 2012 actualizado por: Janssen Pharmaceutica N.V., Belgium
Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy
The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months.
During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma.
Only data already mentioned in your clinical file will be collected.
About 100 adult patients will take part in the study
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responded to bortezomib as first-line treatment, experienced partial response or better, presented with relapsed disease, and were re-treated (second-line) with bortezomib (for at least 3 cycles) after a treatment-free interruption of at least 6 months.
As this is a non-interventional study, no changes to the current treatment that the patient receives will be required, and no additional treatment will be provided by the company.
The decision of the patients to take part in this study will not have any impact on the care they receive.
All the appropriate treatment-related decisions will have been made by the treating physician(s), and only data available from clinical practice will be collected.
Retrospective data will be collected at a single time point for each patient (the data collection visit).
Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria.
After receiving the signed informed consent form (ICF) from the patient (if required by local regulations), the investigator will start documenting the retrospective data for each patient using electronic data capture (eDC).
After confirmation of the patient's eligibility, the patient's last visit, patient characteristics, predefined risk factors (if available), MM-related data, and first- and second-line bortezomib-related data will be documented in the Case Report Form (CRF).
The patient's status after re-treatment with bortezomib, medical resource utilization data, as well as (serious) adverse drug reactions ([S]ADRs) will be collected.
No blood, urine, or other biological samples will be taken, and no additional investigations will be performed.
the current therapy of the patient will be maintained with no changes
Tipo de estudio
De observación
Inscripción (Actual)
35
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.
Ubicaciones de estudio
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Alexandroupoli, Grecia
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Athens, Grecia
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Athens Attica, Grecia
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Patra, Grecia
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Clinic; Hospital
Descripción
Inclusion Criteria:
- Has a current diagnosis/was diagnosed with MM or secretory MM
- Was previously treated with bortezomib-containing chemotherapy
- Responded to bortezomib as first-line treatment
- Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months
- Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria:
- Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade
Has received bortezomib-containing chemotherapy for the first time following a first relapse or later
- Has participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study
- Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
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 |
|---|---|
|
bortezomib retreatment
bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
|
Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
overall response after retreatment
Periodo de tiempo: Day 1
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overall response after retreatment will be assessed from initial diagnosis to the time of data collection
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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number of medical care encounters
Periodo de tiempo: Day 1
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number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of medical care encounters
Periodo de tiempo: Day 1
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duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of hospitalization
Periodo de tiempo: Day 1
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duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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number and character of diagnostic and therapeutic tests and procedures
Periodo de tiempo: Day 1
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number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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outpatient medical encounters and treatments
Periodo de tiempo: Day 1
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outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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safety and tolerability
Periodo de tiempo: Day 1
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safety and tolerability will be evaluated based on the collection of serious and non serious adverse drug reactions from initial diagnosis to the time of data collection
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Day 1
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de marzo de 2011
Finalización del estudio (Actual)
1 de octubre de 2011
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
1 de febrero de 2012
Publicado por primera vez (Estimar)
2 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de junio de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2012
Última verificación
1 de junio de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Neoplasias De Células Plasmáticas
- Mieloma múltiple
- Agentes antineoplásicos
- Bortezomib
Otros números de identificación del estudio
- CR018175
- 26866138MMY4053 (Otro identificador: Janssen CTMS ID)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .