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
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