Real-world Evidence of the Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy (Use of Carfilzomib In Multiple Myeloma Patients)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  KYPROLIS
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  Adult patients with multiple myeloma who had received at least 1 prior therapy prior to receiving carfilzomib in routine clinical practice and who had received at least 1 administration of carfilzomib as prescribed by their physician were considered for enrolment into the study.; ; Inclusion criteria:; 1. age 18 years or older at the time of carfilzomib initiation; 2. at least 1 prior line of MM treatment has been received; 3. Carfilzomib treatment has been initiated per routine practice and is currently ongoing ; 4. At least 1 administration of carfilzomib in a combination regimen has been received; 5. Provided written informed consent prior to abstraction of any data, in countries where written infomred consent is required; ; Exclusion criteria:; 1. Subjects who are receiving carfilzomib treatment within a compassionate use program will not be eligible to take part in this observational study
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple myeloma patients
• Estimated number of subjects:
  651

Study design details

• Main study objective:
  To describe carfilzomib utilisation in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment, and reason for discontinuation
• Outcomes:
  Carfilzomib dose, regimen, dosing frequency, administration schedule, and duration of treatment Carfilzomib dose and frequency changes, interruptions, or delays Reasons for discontinuation of carfilzomib treatment Changes in dose and frequency of concomitant MM therapies given as part of the carfilzomib regimen, Demographic and MM characteristics Treatment history Carfilzomib safety profile Response to treatment Type of relapse ECOG performance status category at MM diagnosis and carfilzomib initiation Unplanned hospitalisations Reason for choosing treatment, dose, regimenConcomitant therapy Cardiovascular assessment per routine practice at carfilzomib initiation and cardiac adverse events
• Data analysis plan:
  The approach to the statistical analysis will be generally descriptive, no formal hypotheses will be tested. Categorical data will be summarised by the number and percentage of subjects in each category. Two-sided 95% CIs will be presented, calculated using Wilson’s method where appropriate. Continuous data will be summarised by mean, SD, median, lower and upper quartiles, and minimum and maximum values. Time-to-event endpoints (DOR and time to progression) will be summarised using Kaplan-Meier methodology. Analyses will be presented overall and by country/region.

Documents

Study results

Abstract of 20150262 Carfilzomib Observational Research Study Report Published Report