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Retrospective Survey of Re-treatment With Bortezomib

11. Juni 2012 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

35

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Alexandroupoli, Griechenland
      • Athens, Griechenland
      • Athens Attica, Griechenland
      • Patra, Griechenland

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Clinic; Hospital

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
overall response after retreatment
Zeitfenster: Day 1
overall response after retreatment will be assessed from initial diagnosis to the time of data collection
Day 1

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
number of medical care encounters
Zeitfenster: 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
Zeitfenster: Day 1
duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
Day 1
duration of hospitalization
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1
outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
Day 1
safety and tolerability
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2011

Studienabschluss (Tatsächlich)

1. Oktober 2011

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Februar 2012

Zuerst gepostet (Schätzen)

2. Februar 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Juni 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2012

Zuletzt verifiziert

1. Juni 2012

Mehr Informationen

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