NCT03091127

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

Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 705 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Timeline

• Start date: 2017-03-14
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2017-03-27
• Last updated: 2022-12-12

Locations

114 sites across 11 countries: Austria, Belgium, Bulgaria, Czechia, France, Greece, Israel, Italy, Netherlands, Norway, Romania