Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe
NCT ID: NCT03091127
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
705 participants
OBSERVATIONAL
2017-03-14
2020-03-17
Brief Summary
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This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.
Detailed Description
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The Primary Objective is to describe carfilzomib utilisation in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation.
* Secondary Objectives:
* Describe the population treated with carfilzomib in terms of demographics, multiple myeloma (MM) disease characteristics, treatment history, and comorbidities.
* Describe the safety profile of carfilzomib in routine clinical practice.
* Describe response to treatment as assessed by the physician and recorded in the medical file.
* Describe healthcare resource utilisation of subjects treated with carfilzomib, in terms of unplanned hospitalisations.
* Describe the reasons for choosing carfilzomib as the MM treatment of choice.
* Describe specific concomitant therapy (bisphosphonates, thromboprophylaxis, antihypertensive treatment, anti-infective treatment) and whether these therapies were used as prophylaxis or as treatment.
* Describe a cardiovascular assessment at carfilzomib regimen initiation and at occurrence of cardiac adverse events, where available per routine care (electrocardiogram \[ECG\], echocardiography, left ventricular ejection fraction).
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* At least one prior line of MM treatment has been received
* Carfilzomib treatment has been initiated per routine practice and is currently ongoing
* At least one administration of carfilzomib in a combination regimen (ie, not monotherapy) has been received
* Provided written informed consent prior to abstraction of any data, in countries where written informed consent is required.
* Subjects who previously completed treatment with carfilzomib in a clinical trial, a compassionate use program or through routine practice, are eligible to take part in the study.
* Subjects who receive radiotherapy concurrently with carfilzomib treatment are also eligible to take part in the study.
* Subjects who initiate carfilzomib treatment on a combination regimen, subsequently discontinue all concomitant medications but remain on carfilzomib monotherapy in later cycles, remain eligible for participation in the study.
* Subjects who are also enrolled in other observational studies in which standard of care is not altered are eligible to take part in the study,
Exclusion Criteria
* Subjects who are receiving carfilzomib treatment within a compassionate use program will not be eligible to take part in this observational study. If a subject who has enrolled into this observational study, also enrolls in a clinical trial in which MM treatment and/or disease management is protocol-specified, the subject becomes ineligible and the subject's data will be censored from the time the subject enrolled the clinical trial.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Krankenhaus Sankt Josef Braunau
Braunau am Inn, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Landeskrankenhaus Hochsteiermark
Leoben, , Austria
Ordensklinikum Linz Elisabethinen
Linz, , Austria
Landeskrankenhaus Rankweil
Rankweil, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Kardinal Schwarzenbergsches Krankenhaus
Schwarzach im Pongau, , Austria
Landeskrankenhaus Steyr
Steyr, , Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, , Austria
Landesklinikum Waidhofen an der Ybbs
Waidhofen an der Ybbs, , Austria
Klinikum Wels - Grieskirchen GmbH
Wels, , Austria
Krankenhaus Wiener Neustadt
Wiener Neustadt, , Austria
Imelda Ziekenhuis Vzw
Bonheiden, , Belgium
Hopital Delta
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Algemeen Ziekenhuis Sint-Dimpna
Geel, , Belgium
Algemeen Ziekenhuis Sint Lucas
Ghent, , Belgium
Centres Hospitaliers Jolimont - Hopital de Jolimont
Haine Saint Paul - La Louviere, , Belgium
Jan Yperman Ziekenhuis
Ieper, , Belgium
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas
Sint-Niklaas, , Belgium
Centre Hospitalier Wallonie Picarde - site imc
Tournai, , Belgium
Centre Hospitalier Regional Verviers
Verviers, , Belgium
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, , Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, , Bulgaria
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Plzen
Pilsen, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Centre Hospitalier Rene Dubos
Amiens, , France
Centre Hospitalier Henri Duffaut
Avignon, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Hopital Henri Mondor
Créteil, , France
Centre Hospitalier Universitaire de Grenoble
Grenoble, , France
Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren
Limoges, , France
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, , France
Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau
Nîmes, , France
Hopital Pitie-Salpetriere
Paris, , France
Hôpital Cochin
Paris, , France
Groupe Hospitalier Necker - Enfants Malades
Paris, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, , France
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
Reims, , France
Centre Hospitalier de Saint Quentin
Saint-Quentin, , France
Clinique Sainte Anne
Strasbourg, , France
University General Hospital of Evros-Alexandroupolis District
Alexandroupoli, , Greece
General Hospital Evangelismos
Athens, , Greece
Errikos Dunant Hospital Center
Athens, , Greece
General Hospital of Athens Georgios Gennimatas
Athens, , Greece
General Hospital of Athens Laiko
Athens, , Greece
Laikon University Hospital
Athens, , Greece
University of Athens School of Medicine Alexandra Hospital
Athens, , Greece
University General Hospital Attikon
Athens, , Greece
Metropolitan General
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
University Hospital of Larissa
Larissa, , Greece
General Hospital of Patras Agios Andreas
Pátrai, , Greece
General University Hospital of Patras Panagia i Voithia
Pátrai, , Greece
Special Anticancer Hospital of Piraeus Metaxa
Piraeus, , Greece
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, , Greece
Rabin Medical Center - Beilinson Hospital
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Unita Sanitaria Locale Toscana Centro
Bagno A Ripoli (FI), , Italy
Ospedale Monsignor Raffaele Dimiccoli
Barletta, , Italy
Azienda Ospedaliera G Rummo
Benevento, , Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , Italy
Presidio Ospedaliero Di Summa Perrino
Brindisi, , Italy
Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale
Cagliari, , Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, , Italy
Azienda Ospedaliera di Alessandro Manzoni Lecco
Lecco, , Italy
Spedali Riuniti di Livorno
Livorno, , Italy
Azienda Ospedaliera Papardo
Messina, , Italy
IRCCS Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Presidio Ospedaliero Andrea Tortora
Pagani (SA), , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, , Italy
Ospedale Civile Spirito Santo
Pescara, , Italy
Azienda Ospedaliera San Carlo
Potenza, , Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Fondazione Policlinico Tor Vergata
Roma, , Italy
Ospedale Sant Eugenio
Roma, , Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona
Salerno, , Italy
Presidio Ospedaliero San Giuseppe Moscati
Taranto, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, , Italy
Azienda Ospedaliero Universitaria Integrata di Udine
Udine, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, , Italy
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Amphia Ziekenhuis, locatie Langendijk
Breda, , Netherlands
Sint Antonius Ziekenhuis, locatie Nieuwegein
Nieuwegein, , Netherlands
Franciscus Vlietland
Schiedam, , Netherlands
HagaZiekenhuis, locatie Leyweg
The Hague, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
Oslo Universitetssykehus HF
Oslo, , Norway
Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Baia Mare, , Romania
Policlinica de Diagnostic Rapid
Brasov, , Romania
Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
Coltea Clinical Hospital
Bucharest, , Romania
Profesor Dr Ion Chiricuta Institut of Oncology
Cluj-Napoca, , Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, , Romania
Iasi Regional Oncology Institute
Iași, , Romania
Spitalul Clinic Dr Gavril Curteanu Oradea
Oradea, , Romania
Targu-Mures County Emergency Clinical Hospital
Târgu Mureş, , Romania
SC Oncomed SRL
Timișoara, , Romania
Countries
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References
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Leleu X, Katodritou E, Kuehr T, Terpos E, Caers J, Zambello R, Brescianini A, Liang T, Wetten S, Badelita SN. Real-world use of carfilzomib combined with lenalidomide and dexamethasone in patients with multiple myeloma in Europe and Israel. EJHaem. 2022 Nov 6;4(1):174-183. doi: 10.1002/jha2.595. eCollection 2023 Feb.
Terpos E, Zambello R, Leleu X, Kuehr T, Badelita SN, Katodritou E, Brescianini A, Liang T, Wetten S, Caers J. Real-World Use and Effectiveness of Carfilzomib Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma in Europe. Cancers (Basel). 2022 Oct 28;14(21):5311. doi: 10.3390/cancers14215311.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20150262
Identifier Type: -
Identifier Source: org_study_id