A french AMBispective, multisite, non-interventional Real-life effectiveness and safety of ELranatanab for the treatment of patients with relapse or refractory multiple myelomA (RRMM) - (AMbreLA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000074
• EU PAS number:
  EUPAS1000000074
• Study ID:
  1000000074
• Official title and acronym:
  A french AMBispective, multisite, non-interventional Real-life effectiveness and safety of ELranatanab for the treatment of patients with relapse or refractory multiple myelomA (RRMM) - (AMbreLA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Non-interventional study conducted in France, an ambispective study based on the inclusion of patient under elranatamb Pfizer product received thanks to an early access program also conducted in France (not compassional).; ; Long-term, non-interventional studies (NIS) that reflect routine care are desirable to continue monitoring the effectiveness and safety of elranatamab after product approval. The existing evidence has been generated from interventional studies, however, the participants enrolled in such interventional studies may not be representative of the real-life population of patients who will receive elranatamab treatment in routine care. ; ; Therefore, this NIS aims to evaluate the effectiveness and safety of elranatamab in real-life clinical settings.
• Study status:
  Planned

Research institution and networks

Institutions

Pfizer

Networks

Cleanweb

Study timelines

Date when funding contract was signed

Planned: 08/04/2024

Study start date

Planned: 30/04/2024

Date of interim report, if expected

Planned: 30/04/2026

Date of final study report

Planned: 31/03/2028

Regulatory

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