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An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

10 giugno 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

532

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
Droga: No intervention
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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Information on treatment sequence for Velcade therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 3 years
Up to 3 years
Number of patients on whom whole-body bone scan will be conducted
Lasso di tempo: Up to 3 years
Up to 3 years
Number of patients on whom radiograph for designated area will be conducted
Lasso di tempo: Up to 3 years
Up to 3 years
Serum immunoglobin and M-protein
Lasso di tempo: Up to 3 years
Up to 3 years
M-protein detected by immunofixation electrophoresis
Lasso di tempo: Up to 3 years
Up to 3 years
Urine light chain M-protein
Lasso di tempo: Up to 3 years
Up to 3 years
Bone marrow puncture and biopsy
Lasso di tempo: Up to 3 years
Up to 3 years
β2-microglobulin
Lasso di tempo: Up to 3 years
Up to 3 years
C-reactive protein
Lasso di tempo: Up to 3 years
Up to 3 years
Lactate dehydrogenase
Lasso di tempo: Up to 3 years
Up to 3 years
Routine blood examination
Lasso di tempo: Up to 3 years
Up to 3 years
Liver function test
Lasso di tempo: Up to 3 years
Up to 3 years
Renal function test
Lasso di tempo: Up to 3 years
Up to 3 years
Serum electrolytes
Lasso di tempo: Up to 3 years
Up to 3 years
Number of patients on concomitant medications
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Indications for Velcade therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
Baseline
Treatment history
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2006

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 maggio 2010

Date di iscrizione allo studio

Primo inviato

27 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2012

Primo Inserito (Stima)

29 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 giugno 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2014

Ultimo verificato

1 giugno 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR006373
  • 26866138MMY4031 (Altro identificatore: Xian-Janssen Pharmaceutical Ltd., China)
  • VEL-CHN-MA-01 (Altro identificatore: Xian-Janssen Pharmaceutical Ltd., China)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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