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Multiple MyelomaNCT03091127

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

An observational study of Multiple Myeloma, run by Amgen at 114 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
705 participants
Where
114 sitesin 11 countries
Study dates
14 Mar 2017to 17 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Multiple Myeloma

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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,

Who cannot join

  • 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.

Trial locations and contacts

114 sites in 11 countries.

114 sites in 11 countries

Italy29 sites

  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Azienda Unita Sanitaria Locale Toscana Centro

    Bagno A Ripoli (FI), 50012

  • Ospedale Monsignor Raffaele Dimiccoli

    Barletta, 76121

  • Azienda Ospedaliera G Rummo

    Benevento, 82100

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • Presidio Ospedaliero Di Summa Perrino

    Brindisi, 72100

  • Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale

    Cagliari, 09121

  • Azienda Ospedaliera Santa Croce e Carle

    Cuneo, 12100

  • Azienda Ospedaliera di Alessandro Manzoni Lecco

    Lecco, 23900

  • Spedali Riuniti di Livorno

    Livorno, 57123

  • Azienda Ospedaliera Papardo

    Messina, 98158

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Presidio Ospedaliero Andrea Tortora

    Pagani (SA), 84016

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06156

  • Ospedale Civile Spirito Santo

    Pescara, 65124

  • Azienda Ospedaliera San Carlo

    Potenza, 85100

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli

    Reggio Calabria, 89124

  • Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

  • Ospedale Sant Eugenio

    Roma, 00144

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona

    Salerno, 84131

  • Presidio Ospedaliero San Giuseppe Moscati

    Taranto, 74123

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

    Torino, 10126

  • Azienda Ospedaliero Universitaria Integrata di Udine

    Udine, 33100

  • Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

    Verona, 37134

Other trials in Italy

Greece17 sites

  • University General Hospital of Evros-Alexandroupolis District

    Alexandroupoli, 68100

  • General Hospital Evangelismos

    Athens, 10676

  • Errikos Dunant Hospital Center

    Athens, 11526

  • General Hospital of Athens Georgios Gennimatas

    Athens, 11527

  • General Hospital of Athens Laiko

    Athens, 11527

  • Laikon University Hospital

    Athens, 11527

  • University of Athens School of Medicine Alexandra Hospital

    Athens, 11528

  • University General Hospital Attikon

    Athens, 12462

  • Metropolitan General

    Athens, 15562

  • Metropolitan Hospital

    Athens, 18547

  • University Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Larissa

    Larissa, 41110

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335

  • General University Hospital of Patras Panagia i Voithia

    Pátrai, 26504

  • Special Anticancer Hospital of Piraeus Metaxa

    Piraeus, 18537

  • Theagenion Cancer Hospital of Thessaloniki

    Thessaloniki, 54007

  • General Hospital of Thessaloniki Georgios Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

France15 sites

  • Centre Hospitalier Rene Dubos

    Amiens, 80054

  • Centre Hospitalier Henri Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64109

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043

  • Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

    Limoges, 87042

  • Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

    Montpellier, 34295

  • Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau

    Nîmes, 30029

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Necker - Enfants Malades

    Paris, 75015

  • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

    Reims, 51056

  • Centre Hospitalier de Saint Quentin

    Saint-Quentin, 02321

  • Clinique Sainte Anne

    Strasbourg, 67000

Other trials in France

Austria12 sites

  • Krankenhaus Sankt Josef Braunau

    Braunau am Inn, 5280

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Landeskrankenhaus Hochsteiermark

    Leoben, 8700

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

  • Landeskrankenhaus Rankweil

    Rankweil, 6830

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Kardinal Schwarzenbergsches Krankenhaus

    Schwarzach im Pongau, 5620

  • Landeskrankenhaus Steyr

    Steyr, 4400

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Landesklinikum Waidhofen an der Ybbs

    Waidhofen an der Ybbs, 3340

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

  • Krankenhaus Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Belgium12 sites

  • Imelda Ziekenhuis Vzw

    Bonheiden, 2820

  • Hopital Delta

    Brussels, 1160

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Algemeen Ziekenhuis Sint-Dimpna

    Geel, 2440

  • Algemeen Ziekenhuis Sint Lucas

    Ghent, 9000

  • Centres Hospitaliers Jolimont - Hopital de Jolimont

    Haine Saint Paul - La Louviere, 7100

  • Jan Yperman Ziekenhuis

    Ieper, 8900

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

  • Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas

    Sint-Niklaas, 9100

  • Centre Hospitalier Wallonie Picarde - site imc

    Tournai, 7500

  • Centre Hospitalier Regional Verviers

    Verviers, 4800

Other trials in Belgium

Romania12 sites

  • Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare

    Baia Mare, 430031

  • Policlinica de Diagnostic Rapid

    Brasov, 500152

  • Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"

    Bucharest, 010825

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Coltea Clinical Hospital

    Bucharest, 030171

  • Profesor Dr Ion Chiricuta Institut of Oncology

    Cluj-Napoca, 400124

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

  • Iasi Regional Oncology Institute

    Iași, 700483

  • Spitalul Clinic Dr Gavril Curteanu Oradea

    Oradea, 410469

  • Targu-Mures County Emergency Clinical Hospital

    Târgu Mureş, 540136

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Netherlands6 sites

  • Rode Kruis Ziekenhuis

    Beverwijk, 1942 LE

  • Amphia Ziekenhuis, locatie Langendijk

    Breda, 4819 EV

  • Sint Antonius Ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Franciscus Vlietland

    Schiedam, 3118 JH

  • HagaZiekenhuis, locatie Leyweg

    The Hague, 2545 CH

  • VieCuri Medisch Centrum

    Venlo, 5912 BL

Other trials in Netherlands

Bulgaria4 sites

  • University Multiprofile Hospital for Active Treatment Alexandrovska

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

    Sofia, 1431

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606

  • Specialized Hospital for Active Treatment of Hematology Diseases EAD

    Sofia, 1756

Other trials in Bulgaria

Czechia4 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Plzen

    Pilsen, 304 60

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Israel2 sites

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Norway1 site

  • Oslo Universitetssykehus HF

    Oslo, 0372

Other trials in Norway

About this study

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

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.

Read the detailed 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).
Medical subject headings
Multiple Myeloma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Carfilzomib starting dose

    Carfilzomib dose at first administration

    Measured: 18 months

  2. Carfilzomib dose

    Carfilzomib dose at subsequent administrations

    Measured: 18 months

  3. Carfilzomib dose modification

    Modification includes change in dose level, dose interruption, and dose delays

    Measured: 18 months

  4. Time to carfilzomib dose modification

    At least one carfilzomib dose modification, escalation or reduction

    Measured: 18 months

  5. Reason for dose modification

    Reason for dose modification or delay

    Measured: 18 months

  6. Number of cycles started

    Number of carfilzomib treatment cycles started throughout study period

    Measured: 18 months

  7. Carfilzomib regimen

    Treatment combination

    Measured: 18 months

  8. Carfilzomib dosing frequency

    Number of administrations per cycle

    Measured: 18 months

  9. Carfilzomib dosing schedule

    Timing of carfilzomib administration within treatment cycle

    Measured: 18 months

  10. Carfilzomib duration of treatment

    Duration of carfilzomib treatment

    Measured: 18 months

  11. Starting dose of concomitant anti-myeloma agents

    Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline

    Measured: 18 months

  12. Dose modification for concomitant anti-myeloma agents

    Modification includes change in dose level, dose interruption, and dose delays

    Measured: 18 months

  13. Reason for frequency modification

    At least 1 change in frequency of carfilzomib administration.

    Measured: 18 months

  14. Reason for change in frequency of concomitant multiple myeloma therapies

    Reason for change in frequency of administration.

    Measured: 18 months

Secondary outcomes (36)

  1. 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

    Measured: 18 months

  2. Eastern Cooperative Oncology Group (ECOG) performance status

    ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.

    Measured: 18 months

  3. Cytogenetic risk profile at diagnosis

    Cytogenetic risk profile at diagnosis

    Measured: 18 months

  4. Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)

    Presence of CRAB features at MM diagnosis

    Measured: 18 months

  5. Presence of comorbidities

    Diagnosed at any point in time before carflzomib regimen initiation

    Measured: 18 months

  6. Previously received anti-myeloma treatment

    Treatment history

    Measured: 18 months

  7. Response to prior treatment

    Response to prior treatment received before initiation of carfilzomib

    Measured: 18 months

  8. Number of prior relapses

    Type of relapse (molecular, hematologic, or symptomatic)

    Measured: 18 months

  9. Adverse event

    All grade 3 or above adverse events.

    Measured: 18 months

  10. Time to adverse event

    All grade 3 or above adverse events

    Measured: 18 months

  11. Electrocardiogram (ECG) changes

    ECG changes as recorded in tests performed per routine practice

    Measured: 18 months

  12. Decrease in left ventricular ejection fraction (LVEF)

    LVEF decrease as recorded in tests performed per routine practice

    Measured: 18 months

  13. Initiation or dose increase of antihypertensive treatment

    Initiation or dose increase of existing antihypertensive treatment

    Measured: 18 months

  14. Initiation or dose increase of existing heart failure treatment

    Initiation or dose increase of existing heart failure treatment

    Measured: 18 months

  15. Response to carfilzomib treatment

    Physician-assessed response as recorded on the medical charts

    Measured: 18 months

  16. Type of relapse

    Molecular, hematologic or symptomatic relapse

    Measured: 18 months

  17. Number of unplanned hospitalisations

    Initiation or dose increase of existing heart failure treatment

    Measured: 18 months

  18. Concomitant therapy not part of the carfilzomib regimen

    Concomitant therapy not part of the carfilzomib regimen

    Measured: 18 months

  19. Planned subsequent treatment regimen

    Planned subsequent treatment regimen catergory

    Measured: 18 months

  20. Patient age

    Patient age

    Measured: 18 months

  21. Patient sex

    Patient sex

    Measured: 18 months

  22. Patient height

    Patient height

    Measured: 18 months

  23. Patient weight

    Patient weight

    Measured: 18 months

  24. MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.

    MRI (magnetic resonance imaging)

    Measured: 18 months

  25. PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.

    PET-CT (positron emission tomography-computed tomography)

    Measured: 18 months

  26. Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.

    Serum M component

    Measured: 18 months

  27. Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.

    Urine M component

    Measured: 18 months

  28. Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.

    Serum albumin

    Measured: 18 months

  29. Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.

    Beta-2-microglobulin

    Measured: 18 months

  30. Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.

    Percent of plasma cells in bone marrow

    Measured: 18 months

  31. Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.

    Lactate dehydrogenase

    Measured: 18 months

  32. ECG (electrocardiogram)

    ECG (electrocardiogram)

    Measured: 18 months

  33. Echocardiogram

    Echocardiogram

    Measured: 18 months

  34. LVEF (left ventricular ejection fraction) assessment

    LVEF (left ventricular ejection fraction) assessment

    Measured: 18 months

  35. Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.

    Computed tomography

    Measured: 18 Months

  36. 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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study start14 Mar 2017
  3. Primary completion17 Mar 2020
  4. Study completion17 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03091127
Sponsor's protocol ID
20150262
Status last verified
Dec 2022
First submitted
30 Jan 2017
Last updated
12 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

  • 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.

    PubMed 36819146

  • 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.

    PubMed 36358731

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Amgen at 114 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Italy, Greece, France, Austria, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carfilzomib starting dose (time frame: 18 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03091127, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.

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