Postmarketing Surveillance Study for Kyprolis® (carfilzomib) in Korea (20160117)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study

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:
  Patients with multiple myeloma who were prescribed treatment of Kyprolis®.; Inclusion Criteria:; 1. Signed and dated informed consent; 2. Patients diagnosed with multiple myeloma who have received at least one prior therapy; 3. Patients who are prescribed with Kyprolis® (in combination with lenalidomide and dexamethasone or in combination with dexamethasone) for the first time; ; Exclusion Criteria:; All contraindications specified in the local product information have to be considered. In addition, patients treated with any regimens not specified in the approved prescribing information of Kyprolis® in Korea should be excluded from the 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:
  700

Study design details

• Main study objective:
  The primary objective of this study is to determine the incidence of adverse events (AEs), serious AEs and adverse drug reactions (ADRs) among patients receiving Kyprolis® in reallife setting in its registered indication(s) as required by MFDS.
• Outcomes:
  Number of patients, subject incidence with adverse events, adverse drug reactions and serious adverse events during the observational period will be calculated and summarized, Overall response rate for disease assessment - Patients with confirmed sCR, CR, VGPR, or PR will be considered to have achieved an overall response
• Data analysis plan:
  Patient demographics, baseline characteristics, medical history and concomitant drug use will be summarized. For the safety analysis, adverse event will be presented using the number of treated patients, incidence proportion and number of patients with events. For the effectiveness analysis, overall response rate at 12 and 24 weeks after drug administration will be analysed

Documents

Study results

20160117 abstract ORSR_Redacted