Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Healthcare resource utilisation
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ELREXFIO
Population studied

Age groups

Adult and elderly population (≥18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

56
Study design details

Study design

This retrospective descriptive cohort study will assess the demographic, clinical, treatment characteristics, HCRU, costs, effectiveness, and safety of MM patients with an elranatamab claim and will use de-identified data from Komodo Health.

Main study objective

Primary
 Objective 1: Describe the demographics, clinical history, and treatment history of
patients in the study
 Objective 2: Describe the administration and treatment management of elranatamab
 Objective 3: Describe all-cause and MM-related HCRU and costs by place of service
of patients in the study

Exploratory
 Exploratory Objective 1: Describe the tolerability and real-world safety of
elranatamab
 Exploratory Objective 2: Describe the effectiveness of elranatamab in terms of
TTNT/D and OS
 Exploratory Objective 3: In a separate cohort, replicate all objectives for patients
with RRMM who initiated teclistamab

Setting

This study will evaluate adult patients with RRMM who initiate elranatamab. Patients will enter (ie.e., index) on the first observed elranatamab claim between 14 August 2023, and March 2024. Limited eligibility criteria will be applied.