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

Amgen

Status: Completed

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT03091127

20150262

Details and patient eligibility

About

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.

Full 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).

Enrollment: 705 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.