Administration of Elranatamab In the Real-World: Treatment Patterns, Healthcare Resource Utilization, Costs, Effectiveness, anD SafEty (ALTITUDE-2)

Study type

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

  Other
• If ‘other’, further details on the scope of the study:
  Demographics, clinical history, treatment history
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ELREXFIO
• Additional medical condition(s):
  Multiple Myeloma

Population studied

• Short description of the study population:
  This study will include adult (≥18 years old) patients with an International Classification of Diseases, tenth revision (ICD-10) code for RRMM (defined as MM ICD-10 codes: C90.0x). The study cohort will include patients with RRMM who initiate elranatamab between August 14, 2023 (US approval date for elranatamab) and most current, available data. The index date for patients in each cohort will be defined as the date of the first prescription or medical claim for elranatamab. Patients will be required to have at least 180 days of continuous closed-claims enrollment before the index date and 30 days after the index date. Select exploratory analyses will also include a teclistamab-exposed cohort.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with multiple myeloma

Study design details

• Study design:
  This will be a retrospective, non-interventional descriptive cohort study using de-identified patient data from US-based Medicare FFS beneficiaries. The study will utilize claims data from the Centers for Medicare and Medicaid Services (CMS), spanning from 2016 through 2025.
• Main study objective:
  The overall research question of this study is to describe the real-world usage of elranatamab. ;
• Setting:
  This study will evaluate adult patients with RRMM who initiate elranatamab or teclistamab. Patients will enter (i.e., index) on the first observed elranatamab or teclistamab claim between August 14, 2023, and the most current, available data. Limited eligibility criteria will be applied. ; Study Period: Start of data (Jan 1, 2016) to the most current, available data.; MM diagnosis window: Start of data (Jan 1, 2016) to index date; Index date: First elranatamab or teclistamab claim after initial MM diagnosis ; Observability: At least 180 days of continuous closed-claims medical and pharmacy enrollment prior to index (inclusive) and 30 days after the index date; Baseline period for MM-related treatments and MM-related comorbidities: MM diagnosis to one day prior to index date; Charlson Comorbidity Index and baseline HCRU assessment window: 180 days prior to index date to index date ; Follow-up: Index date until death, the earliest of end of study period, or end of continuous enrollment (unless otherwise noted). Alternative censoring criteria will be applied for certain outcomes (such as OS, TTD, and TTNT/D).
• Comparators:
  No formal statistical comparisons will be performed between groups.
• Outcomes:
  Primary; • Objective 1: To describe the demographics, clinical history, and treatment history of patients treated with elranatamab; • Objective 2: To describe the administration and treatment management of elranatamab ; • Objective 3: To describe all-cause and MM-related HCRU and associated costs among patients treated with elranatamab; ; Exploratory; • Exploratory Objective 1: To describe the tolerability and real-world safety of elranatamab ; • Exploratory Objective 2: To describe the overall effectiveness of elranatamab in terms of time to next treatment or death (TTNT/D) and overall survival (OS); • Exploratory Objective 3: In a separate cohort, replicate all objectives for patients who initiated teclistamab;
• Data analysis plan:
  This study will be largely descriptive in nature, and no formal statistical comparisons will be performed between groups. All characteristics and outcomes will be reported separately for each cohort. The number of patients who meet study eligibility criteria will be summarized in an attrition table. Inclusion and exclusion criteria will be listed hierarchically and the number of patients remaining at each step will be reported. Patient and treatment characteristics will be summarized using descriptive statistics. Categorical variables will be summarized by the number of available observations, frequency, percentage, and 95% confidence limits. Continuous variables will be summarized by the number of available observations, mean, standard deviation, 95% confidence limits, median, quartiles, minimum, and maximum, where appropriate. The prevalence and incidence, as well as the associated 95% confidence intervals (CI) for each adverse event, will be estimated. Kaplan-Meier methods will be used to estimate the median time to event, including 95% CIs for TTNT/D and OS.