- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01675245
An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
10 de junio de 2014 actualizado por: Xian-Janssen Pharmaceutical Ltd.
Velcade (Bortezomib for Injection) Observational Study
The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.
Descripción general del estudio
Descripción detallada
This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade.
The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase.
In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors.
Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade.
In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period.
Each treatment cycle consists of 21 days.
Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade.
In the follow up phase, patients will be followed for up to three years to document long-term survival data.
For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process.
Safety evaluations will be based on the incidence, intensity, and types of adverse events.
The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.
Tipo de estudio
De observación
Inscripción (Actual)
532
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
No mayor que 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Descripción
Inclusion Criteria:
- Must give informed consent in agreement with local legislation
- Must not have any contraindication listed in package insert
Exclusion Criteria:
- Patients currently participating in another investigational study of Velcade or any other medication
- Patients with severe hepatic or renal impairment
- Patients with platelet count below 25000/μl
- Patients who are considered disqualified for the study by the investigators
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 |
|---|---|
|
Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
|
This is an observational study.
Velcade will be administered as per the recommended regimen.
(Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Information on treatment sequence for Velcade therapy
Periodo de tiempo: Baseline (Day -1) to Day 21
|
Treatment sequence or the line of therapy will be considered on Velcade utilization.
|
Baseline (Day -1) to Day 21
|
|
Information on dosage of Velcade
Periodo de tiempo: Baseline to Day 21
|
Dosage of Velcade will be considered on Velcade utilization.
The unit of dosage will be milligram per square meter body surface area.
|
Baseline to Day 21
|
|
Information on duration of Velcade therapy
Periodo de tiempo: Baseline to Day 21
|
Duration of Velcade therapy will be measured on Velcade utilization.
The unit of duration will be number of days or the length of the course of therapy.
|
Baseline to Day 21
|
|
Information on patient diagnosis for Velcade therapy
Periodo de tiempo: Baseline to Day 21
|
Diagnosis of patients will be considered on Velcade utilization.
|
Baseline to Day 21
|
|
Number of patients with disease response or progression
Periodo de tiempo: Up to 3 years
|
Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.
|
Up to 3 years
|
|
Time to response
Periodo de tiempo: Up to 3 years
|
Time to response is calculated from the start date of the cycle of Velcade therapy.
|
Up to 3 years
|
|
Duration of response
Periodo de tiempo: Up to 3 years
|
Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.
|
Up to 3 years
|
|
Time to progression
Periodo de tiempo: Up to 3 years
|
Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
|
Up to 3 years
|
|
Survival status
Periodo de tiempo: Up to 3 years
|
Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.
|
Up to 3 years
|
|
Number of patients with adverse events
Periodo de tiempo: Up to 3 years
|
Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria [WHO CTC]), and any neurotoxic events by WHO CTC.
|
Up to 3 years
|
|
Number of emergency room visits while using Velcade therapy
Periodo de tiempo: Up to 3 years
|
Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of inpatient hospital stays while using Velcade therapy
Periodo de tiempo: Up to 3 years
|
Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of days for each hospital stay
Periodo de tiempo: Up to 3 years
|
Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of patients on whom therapeutic therapies will be conducted
Periodo de tiempo: Up to 3 years
|
Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of patients on whom chest radiograph will be conducted
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom whole-body bone scan will be conducted
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom radiograph for designated area will be conducted
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Serum immunoglobin and M-protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
M-protein detected by immunofixation electrophoresis
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Urine light chain M-protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Bone marrow puncture and biopsy
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
β2-microglobulin
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
C-reactive protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Lactate dehydrogenase
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Routine blood examination
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Liver function test
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Renal function test
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Serum electrolytes
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on concomitant medications
Periodo de tiempo: Up to 3 years
|
Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy.
Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication.
The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.
|
Up to 3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Indications for Velcade therapy
Periodo de tiempo: Baseline (Day -1)
|
Multiple myeloma patients who receive two or more prior treatments and demonstrate disease progression on the most recent treatment will be indicated for Velcade therapy.
|
Baseline (Day -1)
|
|
Sociodemographics for Velcade therapy
Periodo de tiempo: Baseline
|
Sociodemographics of patients will be assessed, at the initiation of Velcade therapy, such as: gender, date of birth, height, weight, highest degree, and career information.
|
Baseline
|
|
Number of chronic concomitant disease
Periodo de tiempo: Baseline
|
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
|
Baseline
|
|
Treatment history
Periodo de tiempo: Baseline
|
Treatment history will be assessed at the initiation of Velcade therapy.
Treatment history includes: confirmation date of diagnosis of multiple myeloma patients or other patients receiving Velcade therapy; names of diseases for patient receiving Velcade therapy; prior treatments for multiple myeloma; outcomes of prior treatments for multiple myeloma.
|
Baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de marzo de 2006
Finalización primaria (Actual)
1 de mayo de 2010
Finalización del estudio (Actual)
1 de mayo de 2010
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2012
Publicado por primera vez (Estimar)
29 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2014
Última verificación
1 de junio de 2014
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
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
Otros números de identificación del estudio
- CR006373
- 26866138MMY4031 (Otro identificador: Xian-Janssen Pharmaceutical Ltd., China)
- VEL-CHN-MA-01 (Otro identificador: Xian-Janssen Pharmaceutical Ltd., China)
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. .