Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe
- Conditions
- Multiple Myeloma
- Registration Number
- NCT03091127
- Lead Sponsor
- Amgen
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 705
- 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,
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to carfilzomib dose modification 18 months At least one carfilzomib dose modification, escalation or reduction
Carfilzomib regimen 18 months Treatment combination
Carfilzomib dosing frequency 18 months Number of administrations per cycle
Carfilzomib dose modification 18 months Modification includes change in dose level, dose interruption, and dose delays
Reason for dose modification 18 months Reason for dose modification or delay
Number of cycles started 18 months Number of carfilzomib treatment cycles started throughout study period
Starting dose of concomitant anti-myeloma agents 18 months Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline
Carfilzomib starting dose 18 months Carfilzomib dose at first administration
Carfilzomib dose 18 months Carfilzomib dose at subsequent administrations
Carfilzomib dosing schedule 18 months Timing of carfilzomib administration within treatment cycle
Carfilzomib duration of treatment 18 months Duration of carfilzomib treatment
Dose modification for concomitant anti-myeloma agents 18 months Modification includes change in dose level, dose interruption, and dose delays
Reason for frequency modification 18 months At least 1 change in frequency of carfilzomib administration.
Reason for change in frequency of concomitant multiple myeloma therapies 18 months Reason for change in frequency of administration.
- Secondary Outcome Measures
Name Time Method Response to carfilzomib treatment 18 months Physician-assessed response as recorded on the medical charts
Adverse event 18 months All grade 3 or above adverse events.
Patient sex 18 months Patient sex
Patient height 18 months Patient height
Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation. 18 months Beta-2-microglobulin
Number of unplanned hospitalisations 18 months Initiation or dose increase of existing heart failure treatment
Planned subsequent treatment regimen 18 months Planned subsequent treatment regimen catergory
Patient weight 18 months Patient weight
Previously received anti-myeloma treatment 18 months Treatment history
Initiation or dose increase of antihypertensive treatment 18 months Initiation or dose increase of existing antihypertensive treatment
Initiation or dose increase of existing heart failure treatment 18 months Initiation or dose increase of existing heart failure treatment
Eastern Cooperative Oncology Group (ECOG) performance status 18 months ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.
Cytogenetic risk profile at diagnosis 18 months Cytogenetic risk profile at diagnosis
Number of prior relapses 18 months Type of relapse (molecular, hematologic, or symptomatic)
Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain) 18 months Presence of CRAB features at MM diagnosis
Response to prior treatment 18 months Response to prior treatment received before initiation of carfilzomib
Time to adverse event 18 months All grade 3 or above adverse events
Patient age 18 months Patient age
Decrease in left ventricular ejection fraction (LVEF) 18 months LVEF decrease as recorded in tests performed per routine practice
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
Presence of comorbidities 18 months Diagnosed at any point in time before carflzomib regimen initiation
Electrocardiogram (ECG) changes 18 months ECG changes as recorded in tests performed per routine practice
Type of relapse 18 months Molecular, hematologic or symptomatic relapse
Echocardiogram 18 months Echocardiogram
Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation. 18 Months Computed tomography
ECG (electrocardiogram) 18 months ECG (electrocardiogram)
LVEF (left ventricular ejection fraction) assessment 18 months LVEF (left ventricular ejection fraction) assessment
Concomitant therapy not part of the carfilzomib regimen 18 months Concomitant therapy not part of the carfilzomib regimen
MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation. 18 months MRI (magnetic resonance imaging)
PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation. 18 months PET-CT (positron emission tomography-computed tomography)
Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation. 18 months Urine M component
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
Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation. 18 months Serum M component
Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation. 18 months Serum albumin
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
Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation. 18 months Lactate dehydrogenase
Trial Locations
- Locations (114)
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
Scroll for more (104 remaining)Krankenhaus Sankt Josef Braunau🇦🇹Braunau, Austria