Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe
1 other identifier
observational
705
11 countries
114
Brief Summary
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2017
CompletedStudy Start
First participant enrolled
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2020
CompletedDecember 12, 2022
December 1, 2022
3 years
January 30, 2017
December 8, 2022
Conditions
Outcome Measures
Primary Outcomes (14)
Carfilzomib starting dose
Carfilzomib dose at first administration
18 months
Carfilzomib dose
Carfilzomib dose at subsequent administrations
18 months
Carfilzomib dose modification
Modification includes change in dose level, dose interruption, and dose delays
18 months
Time to carfilzomib dose modification
At least one carfilzomib dose modification, escalation or reduction
18 months
Reason for dose modification
Reason for dose modification or delay
18 months
Number of cycles started
Number of carfilzomib treatment cycles started throughout study period
18 months
Carfilzomib regimen
Treatment combination
18 months
Carfilzomib dosing frequency
Number of administrations per cycle
18 months
Carfilzomib dosing schedule
Timing of carfilzomib administration within treatment cycle
18 months
Carfilzomib duration of treatment
Duration of carfilzomib treatment
18 months
Starting dose of concomitant anti-myeloma agents
Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline
18 months
Dose modification for concomitant anti-myeloma agents
Modification includes change in dose level, dose interruption, and dose delays
18 months
Reason for frequency modification
At least 1 change in frequency of carfilzomib administration.
18 months
Reason for change in frequency of concomitant multiple myeloma therapies
Reason for change in frequency of administration.
18 months
Secondary Outcomes (36)
International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation
18 months
Eastern Cooperative Oncology Group (ECOG) performance status
18 months
Cytogenetic risk profile at diagnosis
18 months
Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)
18 months
Presence of comorbidities
18 months
- +31 more secondary outcomes
Eligibility Criteria
Patients with Multiple Myeloma
You may qualify if:
- Age 18 years or older at the time of carfilzomib initiation
- 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,
You may not qualify if:
- Subjects who are enrolled in a carfilzomib clinical trial will not be eligible to additionally take part in this observational study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (114)
Krankenhaus Sankt Josef Braunau
Braunau am Inn, 5280, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Hochsteiermark
Leoben, 8700, Austria
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Landeskrankenhaus Rankweil
Rankweil, 6830, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Kardinal Schwarzenbergsches Krankenhaus
Schwarzach im Pongau, 5620, Austria
Landeskrankenhaus Steyr
Steyr, 4400, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Landesklinikum Waidhofen an der Ybbs
Waidhofen an der Ybbs, 3340, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
Krankenhaus Wiener Neustadt
Wiener Neustadt, 2700, Austria
Imelda Ziekenhuis Vzw
Bonheiden, 2820, Belgium
Hopital Delta
Brussels, 1160, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Algemeen Ziekenhuis Sint-Dimpna
Geel, 2440, Belgium
Algemeen Ziekenhuis Sint Lucas
Ghent, 9000, Belgium
Centres Hospitaliers Jolimont - Hopital de Jolimont
Haine Saint Paul - La Louviere, 7100, Belgium
Jan Yperman Ziekenhuis
Ieper, 8900, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, 4000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas
Sint-Niklaas, 9100, Belgium
Centre Hospitalier Wallonie Picarde - site imc
Tournai, 7500, Belgium
Centre Hospitalier Regional Verviers
Verviers, 4800, Belgium
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, 1431, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606, Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, 1756, Bulgaria
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Plzen
Pilsen, 304 60, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Centre Hospitalier Rene Dubos
Amiens, 80054, France
Centre Hospitalier Henri Duffaut
Avignon, 84902, France
Centre Hospitalier de la Cote Basque
Bayonne, 64109, France
Hopital Henri Mondor
Créteil, 94010, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043, France
Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren
Limoges, 87042, France
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, 34295, France
Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau
Nîmes, 30029, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
Groupe Hospitalier Necker - Enfants Malades
Paris, 75015, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86021, France
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
Reims, 51056, France
Centre Hospitalier de Saint Quentin
Saint-Quentin, 02321, France
Clinique Sainte Anne
Strasbourg, 67000, France
University General Hospital of Evros-Alexandroupolis District
Alexandroupoli, 68100, Greece
General Hospital Evangelismos
Athens, 10676, Greece
Errikos Dunant Hospital Center
Athens, 11526, Greece
General Hospital of Athens Georgios Gennimatas
Athens, 11527, Greece
General Hospital of Athens Laiko
Athens, 11527, Greece
Laikon University Hospital
Athens, 11527, Greece
University of Athens School of Medicine Alexandra Hospital
Athens, 11528, Greece
University General Hospital Attikon
Athens, 12462, Greece
Metropolitan General
Athens, 15562, Greece
Metropolitan Hospital
Athens, 18547, Greece
University Hospital of Heraklion
Heraklion, 71110, Greece
University Hospital of Larissa
Larissa, 41110, Greece
General Hospital of Patras Agios Andreas
Pátrai, 26335, Greece
General University Hospital of Patras Panagia i Voithia
Pátrai, 26504, Greece
Special Anticancer Hospital of Piraeus Metaxa
Piraeus, 18537, Greece
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, 54007, Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, 57010, Greece
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Azienda Unita Sanitaria Locale Toscana Centro
Bagno A Ripoli (FI), 50012, Italy
Ospedale Monsignor Raffaele Dimiccoli
Barletta, 76121, Italy
Azienda Ospedaliera G Rummo
Benevento, 82100, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
Presidio Ospedaliero Di Summa Perrino
Brindisi, 72100, Italy
Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale
Cagliari, 09121, Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, 12100, Italy
Azienda Ospedaliera di Alessandro Manzoni Lecco
Lecco, 23900, Italy
Spedali Riuniti di Livorno
Livorno, 57123, Italy
Azienda Ospedaliera Papardo
Messina, 98158, Italy
IRCCS Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Presidio Ospedaliero Andrea Tortora
Pagani (SA), 84016, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156, Italy
Ospedale Civile Spirito Santo
Pescara, 65124, Italy
Azienda Ospedaliera San Carlo
Potenza, 85100, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, 89124, Italy
Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Fondazione Policlinico Tor Vergata
Roma, 00133, Italy
Ospedale Sant Eugenio
Roma, 00144, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliera Sant Andrea
Roma, 00189, Italy
Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona
Salerno, 84131, Italy
Presidio Ospedaliero San Giuseppe Moscati
Taranto, 74123, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, 10126, Italy
Azienda Ospedaliero Universitaria Integrata di Udine
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, 37134, Italy
Rode Kruis Ziekenhuis
Beverwijk, 1942 LE, Netherlands
Amphia Ziekenhuis, locatie Langendijk
Breda, 4819 EV, Netherlands
Sint Antonius Ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Franciscus Vlietland
Schiedam, 3118 JH, Netherlands
HagaZiekenhuis, locatie Leyweg
The Hague, 2545 CH, Netherlands
VieCuri Medisch Centrum
Venlo, 5912 BL, Netherlands
Oslo Universitetssykehus HF
Oslo, 0372, Norway
Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Baia Mare, 430031, Romania
Policlinica de Diagnostic Rapid
Brasov, 500152, Romania
Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"
Bucharest, 010825, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Fundeni Clinical Institute
Bucharest, 022328, Romania
Coltea Clinical Hospital
Bucharest, 030171, Romania
Profesor Dr Ion Chiricuta Institut of Oncology
Cluj-Napoca, 400124, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Iasi Regional Oncology Institute
Iași, 700483, Romania
Spitalul Clinic Dr Gavril Curteanu Oradea
Oradea, 410469, Romania
Targu-Mures County Emergency Clinical Hospital
Târgu Mureş, 540136, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
Related Publications (2)
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.
PMID: 36819146BACKGROUNDTerpos 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.
PMID: 36358731BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
March 27, 2017
Study Start
March 14, 2017
Primary Completion
March 17, 2020
Study Completion
March 17, 2020
Last Updated
December 12, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request