Administration of elranatamab in the real-world: Treatement patterns, healthcare resource utilization, costs, effectiveness, and safety (ALTITUDE)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  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

• Medicinal product name:
  ELREXFIO
• Study drug International non-proprietary name (INN) or common name:
  ELRANATAMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX32) elranatamab

  elranatamab

Population studied

• Short description of the study population:
  All individuals enrolled in Komodo Health with medical and pharmacy benefit coverage between 01 January 2016 and 25 October 2025.
• 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 the same indication as elranatamab 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.