Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
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

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)

Estimated number of subjects

250
Study design details

Main study objective

The main objective of this study is to describe overall response rate (ORR) in participants with multiple myeloma (MM) who have received at least one prior treatment and initiated therapy with a carfilzomib triplet including an anti-CD38 antibody.

Outcomes

Overall response: defined as the best proportion of best overall response of complete response or better, very good partial response (VGPR), or partial response (PR) by investigator assessment recorded in the participant chart.
Progression-free survival Overall Survival Response duration Subsequent anti-MM therapy Disease progression Overall Response Dose, schedule, cycles, discontinuation, reason for discontinuation, carfilzomib/anti-CD38 antibody dropping/switching Concomitant medications (antibiotics, anti-hypertensives, anti-myeloma therapy, bone targeting agents) Adverse events excluding exempted events

Data analysis plan

Categorical data will be summarised by the number and percentage of participants in each category.
Two-sided 95% CIs will be presented, where appropriate. Continuous data will be summarised by mean, standard deviation (StD), median, lower and upper quartiles, and minimum and maximum values.
Time-to-event endpoints will be summarised using Knowledge Management methodology.