Real-World (RW) Elranatamab Administration: Step Up Dosing (SUD), Treatment Patterns, and Healthcare Resource Utilization (HCRU) in Japan MDV Data (SUMMIT)

Study identification

• EU PAS number:
  EUPAS1000000503
• Study ID:
  1000000503
• Official title and acronym:
  Real-World (RW) Elranatamab Administration: Step Up Dosing (SUD), Treatment Patterns, and Healthcare Resource Utilization (HCRU) in Japan MDV Data (SUMMIT)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This retrospective cohort study will assess the demographics, clinical history, SUD process, HCRU, and safety of elranatamab in multiple myeloma (MM) patients with an elranatamab hospital claim. ; De-identified data from the Japan Medical Data Vision (MDV) will be used. ; ; A retrospective cohort design was chosen because it allows for efficient use of existing RW data to evaluate treatment patterns and outcomes in a newly approved therapy, without the need for prospective data collection. This design is well-suited for descriptive analyses and enables timely insights into the early use of elranatamab in a RW setting. ; ; The primary endpoints include patient demographics, clinical characteristics, and treatment patterns. Secondary endpoints include HCRU and safety outcomes. No formal measures of effect will be calculated. All analysis will be descriptive, with no a priori hypotheses or statistical comparisons between exposure groups. ; ; The study population will be comprised of individuals aged 18 and older who initiated elranatamab between March 26, 2024, the PMDA approval date for elranatamab, and the end of data availability. The study period will be from the start of data availability, April 2008, to the end of data availability in MDV. The study period will remain the same for all study objectives. ; The patient baseline period will be from MM diagnosis to the start of the index treatment. ; The patient index date will be determined as the date of first hospital claim with an administration of elranatamab. The follow-up period will be defined as the period between the index date and the end of the hospital claim of the last elranatamab administration inclusive. ; The SUD period will be defined as the period between the date of the first 44mg/1.1mL vial and the first 76mg/1.9mL vial of elranatamab.
• Study status:
  Ongoing

Research institutions and networks

Networks

STATLOG Inc. and Medical Data Vision (MDV)

Study timelines

Date when funding contract was signed

Actual: 07/02/2025

Study start date

Planned: 15/07/2025

Actual: 07/07/2025

Date of interim report, if expected

Planned: 30/09/2025

Date of final study report

Planned: 30/11/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable