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Retrospective Survey of Re-treatment With Bortezomib

11 juni 2012 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Faktisk)

35

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Alexandroupoli, Grekland
      • Athens, Grekland
      • Athens Attica, Grekland
      • Patra, Grekland

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Clinic; Hospital

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
overall response after retreatment
Tidsram: Day 1
overall response after retreatment will be assessed from initial diagnosis to the time of data collection
Day 1

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
number of medical care encounters
Tidsram: 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
Tidsram: Day 1
duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
Day 1
duration of hospitalization
Tidsram: 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
Tidsram: 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
Tidsram: Day 1
outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
Day 1
safety and tolerability
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2011

Avslutad studie (Faktisk)

1 oktober 2011

Studieregistreringsdatum

Först inskickad

16 juni 2011

Först inskickad som uppfyllde QC-kriterierna

1 februari 2012

Första postat (Uppskatta)

2 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 juni 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2012

Senast verifierad

1 juni 2012

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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