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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT03091127
Collaborator
(none)
705
Enrollment
115
Locations
36.1
Actual Duration (Months)
6.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    705 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.
    Actual Study Start Date :
    Mar 14, 2017
    Actual Primary Completion Date :
    Mar 17, 2020
    Actual Study Completion Date :
    Mar 17, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Carfilzomib starting dose [18 months]

      Carfilzomib dose at first administration

    2. Carfilzomib dose [18 months]

      Carfilzomib dose at subsequent administrations

    3. Carfilzomib dose modification [18 months]

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

    4. Time to carfilzomib dose modification [18 months]

      At least one carfilzomib dose modification, escalation or reduction

    5. Reason for dose modification [18 months]

      Reason for dose modification or delay

    6. Number of cycles started [18 months]

      Number of carfilzomib treatment cycles started throughout study period

    7. Carfilzomib regimen [18 months]

      Treatment combination

    8. Carfilzomib dosing frequency [18 months]

      Number of administrations per cycle

    9. Carfilzomib dosing schedule [18 months]

      Timing of carfilzomib administration within treatment cycle

    10. Carfilzomib duration of treatment [18 months]

      Duration of carfilzomib treatment

    11. Starting dose of concomitant anti-myeloma agents [18 months]

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

    12. Dose modification for concomitant anti-myeloma agents [18 months]

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

    13. Reason for frequency modification [18 months]

      At least 1 change in frequency of carfilzomib administration.

    14. Reason for change in frequency of concomitant multiple myeloma therapies [18 months]

      Reason for change in frequency of administration.

    Secondary Outcome Measures

    1. International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation [18 months]

      International Staging System (ISS) score of I, II, III, or unkown

    2. Eastern Cooperative Oncology Group (ECOG) performance status [18 months]

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

    3. Cytogenetic risk profile at diagnosis [18 months]

      Cytogenetic risk profile at diagnosis

    4. Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain) [18 months]

      Presence of CRAB features at MM diagnosis

    5. Presence of comorbidities [18 months]

      Diagnosed at any point in time before carflzomib regimen initiation

    6. Previously received anti-myeloma treatment [18 months]

      Treatment history

    7. Response to prior treatment [18 months]

      Response to prior treatment received before initiation of carfilzomib

    8. Number of prior relapses [18 months]

      Type of relapse (molecular, hematologic, or symptomatic)

    9. Adverse event [18 months]

      All grade 3 or above adverse events.

    10. Time to adverse event [18 months]

      All grade 3 or above adverse events

    11. Electrocardiogram (ECG) changes [18 months]

      ECG changes as recorded in tests performed per routine practice

    12. Decrease in left ventricular ejection fraction (LVEF) [18 months]

      LVEF decrease as recorded in tests performed per routine practice

    13. Initiation or dose increase of antihypertensive treatment [18 months]

      Initiation or dose increase of existing antihypertensive treatment

    14. Initiation or dose increase of existing heart failure treatment [18 months]

      Initiation or dose increase of existing heart failure treatment

    15. Response to carfilzomib treatment [18 months]

      Physician-assessed response as recorded on the medical charts

    16. Type of relapse [18 months]

      Molecular, hematologic or symptomatic relapse

    17. Number of unplanned hospitalisations [18 months]

      Initiation or dose increase of existing heart failure treatment

    18. Concomitant therapy not part of the carfilzomib regimen [18 months]

      Concomitant therapy not part of the carfilzomib regimen

    19. Planned subsequent treatment regimen [18 months]

      Planned subsequent treatment regimen catergory

    20. Patient age [18 months]

      Patient age

    21. Patient sex [18 months]

      Patient sex

    22. Patient height [18 months]

      Patient height

    23. Patient weight [18 months]

      Patient weight

    24. MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation. [18 months]

      MRI (magnetic resonance imaging)

    25. PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation. [18 months]

      PET-CT (positron emission tomography-computed tomography)

    26. Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Serum M component

    27. Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Urine M component

    28. Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Serum albumin

    29. Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Beta-2-microglobulin

    30. Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Percent of plasma cells in bone marrow

    31. Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation. [18 months]

      Lactate dehydrogenase

    32. ECG (electrocardiogram) [18 months]

      ECG (electrocardiogram)

    33. Echocardiogram [18 months]

      Echocardiogram

    34. LVEF (left ventricular ejection fraction) assessment [18 months]

      LVEF (left ventricular ejection fraction) assessment

    35. Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation. [18 Months]

      Computed tomography

    36. Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation [18 months]

      Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krankenhaus Sankt Josef Braunau Braunau Austria 5280
    2 Medizinische Universitaet Innsbruck Innsbruck Austria 6020
    3 Landeskrankenhaus Hochsteiermark Leoben Austria 8700
    4 Ordensklinikum Linz Elisabethinen Linz Austria 4020
    5 Landeskrankenhaus Rankweil Rankweil Austria 6830
    6 Landeskrankenhaus Salzburg Salzburg Austria 5020
    7 Kardinal Schwarzenbergsches Krankenhaus Schwarzach im Pongau Austria 5620
    8 Landeskrankenhaus Steyr Steyr Austria 4400
    9 Landesklinikum Waidhofen an der Ybbs Waidhofen an der Ybbs Austria 3340
    10 Klinikum Wels - Grieskirchen GmbH Wels Austria 4600
    11 Krankenhaus Wiener Neustadt Wiener Neustadt Austria 2700
    12 Universitaetsklinikum Allgemeines Krankenhaus Wien Wien Austria 1090
    13 Imelda Ziekenhuis Vzw Bonheiden Belgium 2820
    14 Hopital Delta Brussels Belgium 1160
    15 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    16 Algemeen Ziekenhuis Sint-Dimpna Geel Belgium 2440
    17 Algemeen Ziekenhuis Sint Lucas Gent Belgium 9000
    18 Centres Hospitaliers Jolimont - Hopital de Jolimont Haine Saint Paul - La Louviere Belgium 7100
    19 Jan Yperman Ziekenhuis Ieper Belgium 8900
    20 Centre Hospitalier Regional de la Citadelle Liege Belgium 4000
    21 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 4000
    22 Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas Sint-Niklaas Belgium 9100
    23 Centre Hospitalier Wallonie Picarde - site imc Tournai Belgium 7500
    24 Centre Hospitalier Regional Verviers Verviers Belgium 4800
    25 University Multiprofile Hospital for Active Treatment Alexandrovska Sofia Bulgaria 1431
    26 University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia Bulgaria 1431
    27 Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia Sofia Bulgaria 1606
    28 Specialized Hospital for Active Treatment of Hematology Diseases EAD Sofia Bulgaria 1756
    29 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    30 Fakultni nemocnice Olomouc Olomouc Czechia 775 20
    31 Fakultni nemocnice Plzen Plzen Czechia 304 60
    32 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
    33 Centre Hospitalier Rene Dubos Amiens Cedex 1 France 80054
    34 Centre Hospitalier Henri Duffaut Avignon Cedex 9 France 84902
    35 Centre Hospitalier de la Cote Basque Bayonne France 64109
    36 Hopital Henri Mondor Creteil France 94010
    37 Centre Hospitalier Universitaire de Grenoble Grenoble Cedex 9 France 38043
    38 Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren Limoges Cedex France 87042
    39 Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi Montpellier cedex 5 France 34295
    40 Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau Nimes cedex 09 France 30029
    41 Hopital Pitie-Salpetriere Paris France 75013
    42 Hôpital Cochin Paris France 75014
    43 Groupe Hospitalier Necker - Enfants Malades Paris France 75015
    44 Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie Poitiers Cedex France 86021
    45 Centre Hospitalier Universitaire de Reims - Hopital Robert Debre Reims Cedex France 51056
    46 Centre Hospitalier de Saint Quentin Saint Quentin France 02321
    47 Clinique Sainte Anne Strasbourg France 67000
    48 University General Hospital of Evros-Alexandroupolis District Alexandroupoli Greece 68100
    49 General Hospital Evangelismos Athens Greece 10676
    50 Errikos Dunant Hospital Center Athens Greece 11526
    51 General Hospital of Athens Georgios Gennimatas Athens Greece 11527
    52 General Hospital of Athens Laiko Athens Greece 11527
    53 Laikon University Hospital Athens Greece 11527
    54 University of Athens School of Medicine Alexandra Hospital Athens Greece 11528
    55 University General Hospital Attikon Athens Greece 12462
    56 Metropolitan General Athens Greece 15562
    57 Metropolitan Hospital Athens Greece 18547
    58 University Hospital of Heraklion Heraklion Greece 71110
    59 University Hospital of Larissa Larissa Greece 41110
    60 General Hospital of Patras Agios Andreas Patra Greece 26335
    61 General University Hospital of Patras Panagia i Voithia Patra Greece 26504
    62 Special Anticancer Hospital of Piraeus Metaxa Piraeus Greece 18537
    63 Theagenion Cancer Hospital of Thessaloniki Thessaloniki Greece 54007
    64 General Hospital of Thessaloniki Georgios Papanikolaou Thessaloniki Greece 57010
    65 Rabin Medical Center - Beilinson Hospital Petah Tiqva Israel 4941492
    66 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    67 Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo Alessandria Italy 15121
    68 Azienda Unita Sanitaria Locale Toscana Centro Bagno A Ripoli (FI) Italy 50012
    69 Ospedale Monsignor Raffaele Dimiccoli Barletta Italy 76121
    70 Azienda Ospedaliera G Rummo Benevento Italy 82100
    71 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy 24127
    72 Presidio Ospedaliero Di Summa Perrino Brindisi Italy 72100
    73 Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale Cagliari Italy 09121
    74 Azienda Ospedaliera Santa Croce e Carle Cuneo Italy 12100
    75 Azienda Ospedaliera di Alessandro Manzoni Lecco Lecco Italy 23900
    76 Spedali Riuniti di Livorno Livorno Italy 57123
    77 Azienda Ospedaliera Papardo Messina Italy 98158
    78 IRCCS Istituto Europeo di Oncologia Milano Italy 20141
    79 Azienda Ospedaliera di Padova Padova Italy 35128
    80 Presidio Ospedaliero Andrea Tortora Pagani (SA) Italy 84016
    81 Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy 90146
    82 Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia Perugia Italy 06156
    83 Ospedale Civile Spirito Santo Pescara Italy 65124
    84 Azienda Ospedaliera San Carlo Potenza Italy 85100
    85 Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy 89124
    86 Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova Reggio Emilia Italy 42100
    87 Fondazione Policlinico Tor Vergata Roma Italy 00133
    88 Ospedale Sant Eugenio Roma Italy 00144
    89 Azienda Ospedaliera Policlinico Umberto I Roma Italy 00161
    90 Azienda Ospedaliera Sant Andrea Roma Italy 00189
    91 Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona Salerno Italy 84131
    92 Presidio Ospedaliero San Giuseppe Moscati Taranto Italy 74123
    93 Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette Torino Italy 10126
    94 Azienda Ospedaliero Universitaria Integrata di Udine Udine Italy 33100
    95 Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma Verona Italy 37134
    96 Rode Kruis Ziekenhuis Beverwijk Netherlands 1942 LE
    97 Amphia Ziekenhuis, locatie Langendijk Breda Netherlands 4819 EV
    98 HagaZiekenhuis, locatie Leyweg Den Haag Netherlands 2545 CH
    99 Sint Antonius Ziekenhuis, locatie Nieuwegein Nieuwegein Netherlands 3435 CM
    100 Franciscus Vlietland Schiedam Netherlands 3118 JH
    101 VieCuri Medisch Centrum Venlo Netherlands 5912 BL
    102 Oslo Universitetssykehus HF Oslo Norway 0372
    103 Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare Baia Mare Romania 430031
    104 Policlinica de Diagnostic Rapid Brasov Romania 500152
    105 Spitalul Clinic Colentina Bucharest Romania 020125
    106 Fundeni Clinical Institute Bucharest Romania 022328
    107 Coltea Clinical Hospital Bucharest Romania 030171
    108 Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila" Bucuresti Romania 010825
    109 Fundeni Clinical Institute Bucuresti Romania 022328
    110 Profesor Dr Ion Chiricuta Institut of Oncology Cluj-Napoca Romania 400124
    111 Spitalul Clinic Municipal Filantropia Craiova Craiova Romania 200143
    112 Iasi Regional Oncology Institute Iasi Romania 700483
    113 Spitalul Clinic Dr Gavril Curteanu Oradea Oradea Romania 410469
    114 Targu-Mures County Emergency Clinical Hospital Targu Mures Romania 540136
    115 SC Oncomed SRL Timisoara Romania 300239

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03091127
    Other Study ID Numbers:
    • 20150262
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Oct 11, 2021