Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe

Multiple Myeloma Clinical Trial

Official title:

Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091127
• Other study ID #: 20150262
• Status: Completed
• Start date: March 14, 2017
• Est. completion date: March 17, 2020

Study information

• Verified date: December 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Austria	Krankenhaus Sankt Josef Braunau	Braunau
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	Landesklinikum Waidhofen an der Ybbs	Waidhofen an der Ybbs
Austria	Klinikum Wels - Grieskirchen GmbH	Wels
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
Austria	Krankenhaus Wiener Neustadt	Wiener Neustadt
Belgium	Imelda Ziekenhuis Vzw	Bonheiden
Belgium	Hopital Delta	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Algemeen Ziekenhuis Sint-Dimpna	Geel
Belgium	Algemeen Ziekenhuis Sint Lucas	Gent
Belgium	Centres Hospitaliers Jolimont - Hopital de Jolimont	Haine Saint Paul - La Louviere
Belgium	Jan Yperman Ziekenhuis	Ieper
Belgium	Centre Hospitalier Regional de la Citadelle	Liege
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas	Sint-Niklaas
Belgium	Centre Hospitalier Wallonie Picarde - site imc	Tournai
Belgium	Centre Hospitalier Regional Verviers	Verviers
Bulgaria	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Hematology Diseases EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Alexandrovska	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD	Sofia
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Plzen	Plzen
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
France	Centre Hospitalier Rene Dubos	Amiens Cedex 1
France	Centre Hospitalier Henri Duffaut	Avignon Cedex 9
France	Centre Hospitalier de la Cote Basque	Bayonne
France	Hopital Henri Mondor	Creteil
France	Centre Hospitalier Universitaire de Grenoble	Grenoble Cedex 9
France	Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren	Limoges Cedex
France	Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi	Montpellier cedex 5
France	Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau	Nimes cedex 09
France	Groupe Hospitalier Necker - Enfants Malades	Paris
France	Hôpital Cochin	Paris
France	Hopital Pitie-Salpetriere	Paris
France	Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie	Poitiers Cedex
France	Centre Hospitalier Universitaire de Reims - Hopital Robert Debre	Reims Cedex
France	Centre Hospitalier de Saint Quentin	Saint Quentin
France	Clinique Sainte Anne	Strasbourg
Greece	University General Hospital of Evros-Alexandroupolis District	Alexandroupoli
Greece	Errikos Dunant Hospital Center	Athens
Greece	General Hospital Evangelismos	Athens
Greece	General Hospital of Athens Georgios Gennimatas	Athens
Greece	General Hospital of Athens Laiko	Athens
Greece	Laikon University Hospital	Athens
Greece	Metropolitan General	Athens
Greece	Metropolitan Hospital	Athens
Greece	University General Hospital Attikon	Athens
Greece	University of Athens School of Medicine Alexandra Hospital	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University Hospital of Larissa	Larissa
Greece	General Hospital of Patras Agios Andreas	Patra
Greece	General University Hospital of Patras Panagia i Voithia	Patra
Greece	Special Anticancer Hospital of Piraeus Metaxa	Piraeus
Greece	General Hospital of Thessaloniki Georgios Papanikolaou	Thessaloniki
Greece	Theagenion Cancer Hospital of Thessaloniki	Thessaloniki
Israel	Rabin Medical Center - Beilinson Hospital	Petah Tiqva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	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	Milano
Italy	Azienda Ospedaliera di Padova	Padova
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	Azienda Ospedaliera Policlinico Umberto I	Roma
Italy	Azienda Ospedaliera Sant Andrea	Roma
Italy	Fondazione Policlinico Tor Vergata	Roma
Italy	Ospedale Sant Eugenio	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
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Amphia Ziekenhuis, locatie Langendijk	Breda
Netherlands	HagaZiekenhuis, locatie Leyweg	Den Haag
Netherlands	Sint Antonius Ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Franciscus Vlietland	Schiedam
Netherlands	VieCuri Medisch Centrum	Venlo
Norway	Oslo Universitetssykehus HF	Oslo
Romania	Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare	Baia Mare
Romania	Policlinica de Diagnostic Rapid	Brasov
Romania	Coltea Clinical Hospital	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	Spitalul Clinic Colentina	Bucharest
Romania	Fundeni Clinical Institute	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"	Bucuresti
Romania	Profesor Dr Ion Chiricuta Institut of Oncology	Cluj-Napoca
Romania	Spitalul Clinic Municipal Filantropia Craiova	Craiova
Romania	Iasi Regional Oncology Institute	Iasi
Romania	Spitalul Clinic Dr Gavril Curteanu Oradea	Oradea
Romania	Targu-Mures County Emergency Clinical Hospital	Targu Mures
Romania	SC Oncomed SRL	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czechia,  France,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Romania, 

References & Publications (2)

Leleu, X, Katodritou, E, Kuehr, T, Terpos, E, Caers, J, Zambello, R, et al. Real-world use of carfilzomib combined with lenalidomide and dexamethasone in patients with multiple myeloma in Europe and Israel. eJHaem. 2022; 1- 10. 10.1002/jha2.595

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carfilzomib starting dose	Carfilzomib dose at first administration	18 months
Primary	Carfilzomib dose	Carfilzomib dose at subsequent administrations	18 months
Primary	Carfilzomib dose modification	Modification includes change in dose level, dose interruption, and dose delays	18 months
Primary	Time to carfilzomib dose modification	At least one carfilzomib dose modification, escalation or reduction	18 months
Primary	Reason for dose modification	Reason for dose modification or delay	18 months
Primary	Number of cycles started	Number of carfilzomib treatment cycles started throughout study period	18 months
Primary	Carfilzomib regimen	Treatment combination	18 months
Primary	Carfilzomib dosing frequency	Number of administrations per cycle	18 months
Primary	Carfilzomib dosing schedule	Timing of carfilzomib administration within treatment cycle	18 months
Primary	Carfilzomib duration of treatment	Duration of carfilzomib treatment	18 months
Primary	Starting dose of concomitant anti-myeloma agents	Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline	18 months
Primary	Dose modification for concomitant anti-myeloma agents	Modification includes change in dose level, dose interruption, and dose delays	18 months
Primary	Reason for frequency modification	At least 1 change in frequency of carfilzomib administration.	18 months
Primary	Reason for change in frequency of concomitant multiple myeloma therapies	Reason for change in frequency of administration.	18 months
Secondary	International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation	International Staging System (ISS) score of I, II, III, or unkown	18 months
Secondary	Eastern Cooperative Oncology Group (ECOG) performance status	ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.	18 months
Secondary	Cytogenetic risk profile at diagnosis	Cytogenetic risk profile at diagnosis	18 months
Secondary	Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)	Presence of CRAB features at MM diagnosis	18 months
Secondary	Presence of comorbidities	Diagnosed at any point in time before carflzomib regimen initiation	18 months
Secondary	Previously received anti-myeloma treatment	Treatment history	18 months
Secondary	Response to prior treatment	Response to prior treatment received before initiation of carfilzomib	18 months
Secondary	Number of prior relapses	Type of relapse (molecular, hematologic, or symptomatic)	18 months
Secondary	Adverse event	All grade 3 or above adverse events.	18 months
Secondary	Time to adverse event	All grade 3 or above adverse events	18 months
Secondary	Electrocardiogram (ECG) changes	ECG changes as recorded in tests performed per routine practice	18 months
Secondary	Decrease in left ventricular ejection fraction (LVEF)	LVEF decrease as recorded in tests performed per routine practice	18 months
Secondary	Initiation or dose increase of antihypertensive treatment	Initiation or dose increase of existing antihypertensive treatment	18 months
Secondary	Initiation or dose increase of existing heart failure treatment	Initiation or dose increase of existing heart failure treatment	18 months
Secondary	Response to carfilzomib treatment	Physician-assessed response as recorded on the medical charts	18 months
Secondary	Type of relapse	Molecular, hematologic or symptomatic relapse	18 months
Secondary	Number of unplanned hospitalisations	Initiation or dose increase of existing heart failure treatment	18 months
Secondary	Concomitant therapy not part of the carfilzomib regimen	Concomitant therapy not part of the carfilzomib regimen	18 months
Secondary	Planned subsequent treatment regimen	Planned subsequent treatment regimen catergory	18 months
Secondary	Patient age	Patient age	18 months
Secondary	Patient sex	Patient sex	18 months
Secondary	Patient height	Patient height	18 months
Secondary	Patient weight	Patient weight	18 months
Secondary	MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.	MRI (magnetic resonance imaging)	18 months
Secondary	PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.	PET-CT (positron emission tomography-computed tomography)	18 months
Secondary	Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.	Serum M component	18 months
Secondary	Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.	Urine M component	18 months
Secondary	Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.	Serum albumin	18 months
Secondary	Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.	Beta-2-microglobulin	18 months
Secondary	Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.	Percent of plasma cells in bone marrow	18 months
Secondary	Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.	Lactate dehydrogenase	18 months
Secondary	ECG (electrocardiogram)	ECG (electrocardiogram)	18 months
Secondary	Echocardiogram	Echocardiogram	18 months
Secondary	LVEF (left ventricular ejection fraction) assessment	LVEF (left ventricular ejection fraction) assessment	18 months
Secondary	Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.	Computed tomography	18 Months
Secondary	Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation	Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation	18 months

External Links

•   AmgenTrials clinical trials website