Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe
Study Details
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.
Protocol Summary
Carfilzomib starting dose
Timeframe: 18 months
Carfilzomib dose
Timeframe: 18 months
Carfilzomib dose modification
Timeframe: 18 months
Time to carfilzomib dose modification
Timeframe: 18 months
Reason for dose modification
Timeframe: 18 months
Number of cycles started
Timeframe: 18 months
Carfilzomib regimen
Timeframe: 18 months
Carfilzomib dosing frequency
Timeframe: 18 months
Carfilzomib dosing schedule
Timeframe: 18 months
Carfilzomib duration of treatment
Timeframe: 18 months
Starting dose of concomitant anti-myeloma agents
Timeframe: 18 months
Dose modification for concomitant anti-myeloma agents
Timeframe: 18 months
Reason for frequency modification
Timeframe: 18 months
Reason for change in frequency of concomitant multiple myeloma therapies
Timeframe: 18 months
International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation
Timeframe: 18 months
Eastern Cooperative Oncology Group (ECOG) performance status
Timeframe: 18 months
Cytogenetic risk profile at diagnosis
Timeframe: 18 months
Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)
Timeframe: 18 months
Presence of comorbidities
Timeframe: 18 months
Previously received anti-myeloma treatment
Timeframe: 18 months
Response to prior treatment
Timeframe: 18 months
Number of prior relapses
Timeframe: 18 months
Adverse event
Timeframe: 18 months
Time to adverse event
Timeframe: 18 months
Electrocardiogram (ECG) changes
Timeframe: 18 months
Decrease in left ventricular ejection fraction (LVEF)
Timeframe: 18 months
Initiation or dose increase of antihypertensive treatment
Timeframe: 18 months
Initiation or dose increase of existing heart failure treatment
Timeframe: 18 months
Response to carfilzomib treatment
Timeframe: 18 months
Type of relapse
Timeframe: 18 months
Number of unplanned hospitalisations
Timeframe: 18 months
Concomitant therapy not part of the carfilzomib regimen
Timeframe: 18 months
Planned subsequent treatment regimen
Timeframe: 18 months
Patient age
Timeframe: 18 months
Patient sex
Timeframe: 18 months
Patient height
Timeframe: 18 months
Patient weight
Timeframe: 18 months
MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
PET-CT (positron emission tomography–computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.
Timeframe: 18 months
ECG (electrocardiogram)
Timeframe: 18 months
Echocardiogram
Timeframe: 18 months
LVEF (left ventricular ejection fraction) assessment
Timeframe: 18 months
Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.
Timeframe: 18 Months
Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation
Timeframe: 18 months