Study Complete
Sponsor ID
20150262

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

Sponsor ID
20150262
Clinicaltrials.gov ID
NCT03091127
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 4
Product
Kyprolis
Type
Observational
Masking
N/A
Enrollment
705
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Landeskrankenhaus Rankweil
Rankweil, Austria, 6830
Status
Completed
Location
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Status
Completed
Location
Kardinal Schwarzenbergsches Krankenhaus
Schwarzach im Pongau, Austria, 5620
Status
Completed
Location
Krankenhaus Wiener Neustadt
Wiener Neustadt, Austria, 2700
Status
Terminated
Location
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Status
Completed
Location
Krankenhaus Sankt Josef Braunau
Braunau, Austria, 5280
Status
Completed
Showing {first} - {last} of {total} Results