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An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

10 de junho de 2014 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

532

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Information on treatment sequence for Velcade therapy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 3 years
Up to 3 years
Number of patients on whom whole-body bone scan will be conducted
Prazo: Up to 3 years
Up to 3 years
Number of patients on whom radiograph for designated area will be conducted
Prazo: Up to 3 years
Up to 3 years
Serum immunoglobin and M-protein
Prazo: Up to 3 years
Up to 3 years
M-protein detected by immunofixation electrophoresis
Prazo: Up to 3 years
Up to 3 years
Urine light chain M-protein
Prazo: Up to 3 years
Up to 3 years
Bone marrow puncture and biopsy
Prazo: Up to 3 years
Up to 3 years
β2-microglobulin
Prazo: Up to 3 years
Up to 3 years
C-reactive protein
Prazo: Up to 3 years
Up to 3 years
Lactate dehydrogenase
Prazo: Up to 3 years
Up to 3 years
Routine blood examination
Prazo: Up to 3 years
Up to 3 years
Liver function test
Prazo: Up to 3 years
Up to 3 years
Renal function test
Prazo: Up to 3 years
Up to 3 years
Serum electrolytes
Prazo: Up to 3 years
Up to 3 years
Number of patients on concomitant medications
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Indications for Velcade therapy
Prazo: 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
Prazo: 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
Prazo: Baseline
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
Baseline
Treatment history
Prazo: 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

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Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2006

Conclusão Primária (Real)

1 de maio de 2010

Conclusão do estudo (Real)

1 de maio de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

27 de agosto de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de agosto de 2012

Primeira postagem (Estimativa)

29 de agosto de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de junho de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de junho de 2014

Última verificação

1 de junho de 2014

Mais Informações

Termos relacionados a este estudo

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