An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
Velcade (Bortezomib for Injection) Observational Study
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
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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
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
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Treatment sequence or the line of therapy will be considered on Velcade utilization.
|
Baseline (Day -1) to Day 21
|
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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
|
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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.
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Baseline to Day 21
|
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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.
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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.
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Up to 3 years
|
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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.
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Up to 3 years
|
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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.
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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.
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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.
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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
|
|
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Number of patients on whom whole-body bone scan will be conducted
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Number of patients on whom radiograph for designated area will be conducted
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Serum immunoglobin and M-protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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M-protein detected by immunofixation electrophoresis
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Urine light chain M-protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Bone marrow puncture and biopsy
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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β2-microglobulin
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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C-reactive protein
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Lactate dehydrogenase
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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Routine blood examination
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
|
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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
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
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
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
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)
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