- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01524445
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
Bedingungen
Intervention / Behandlung
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
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Alexandroupoli, Griechenland
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Athens, Griechenland
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Athens Attica, Griechenland
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Patra, Griechenland
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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 |
|---|---|
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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
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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
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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overall response after retreatment
Zeitfenster: Day 1
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overall response after retreatment will be assessed from initial diagnosis to the time of data collection
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Day 1
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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number of medical care encounters
Zeitfenster: Day 1
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number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of medical care encounters
Zeitfenster: Day 1
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duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of hospitalization
Zeitfenster: Day 1
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duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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number and character of diagnostic and therapeutic tests and procedures
Zeitfenster: Day 1
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number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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outpatient medical encounters and treatments
Zeitfenster: Day 1
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outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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safety and tolerability
Zeitfenster: Day 1
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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
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Day 1
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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
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Hämatologische Erkrankungen
- Hämorrhagische Störungen
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Neubildungen, Plasmazelle
- Multiples Myelom
- Antineoplastische Mittel
- Bortezomib
Andere Studien-ID-Nummern
- CR018175
- 26866138MMY4053 (Andere Kennung: Janssen CTMS ID)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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