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Retrospective Survey of Re-treatment With Bortezomib

11 giugno 2012 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

35

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Alexandroupoli, Grecia
      • Athens, Grecia
      • Athens Attica, Grecia
      • Patra, Grecia

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Clinic; Hospital

Descrizione

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

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
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
overall response after retreatment
Lasso di tempo: Day 1
overall response after retreatment will be assessed from initial diagnosis to the time of data collection
Day 1

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
number of medical care encounters
Lasso di tempo: Day 1
number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
Day 1
duration of medical care encounters
Lasso di tempo: Day 1
duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
Day 1
duration of hospitalization
Lasso di tempo: Day 1
duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection
Day 1
number and character of diagnostic and therapeutic tests and procedures
Lasso di tempo: Day 1
number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection
Day 1
outpatient medical encounters and treatments
Lasso di tempo: Day 1
outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
Day 1
safety and tolerability
Lasso di tempo: Day 1
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
Day 1

Collaboratori e investigatori

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

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 2011

Completamento dello studio (Effettivo)

1 ottobre 2011

Date di iscrizione allo studio

Primo inviato

16 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

1 febbraio 2012

Primo Inserito (Stima)

2 febbraio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2012

Ultimo verificato

1 giugno 2012

Maggiori informazioni

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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