BLENREP Effectiveness and Safety in Multiple Myeloma (BEaMM) – Real-World Evidence on Patients Taking Belantamab Mafodotin in Europe (217240)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49148
• EU PAS number:
  EUPAS44701
• Study ID:
  49148
• Official title and acronym:
  BLENREP Effectiveness and Safety in Multiple Myeloma (BEaMM) – Real-World Evidence on Patients Taking Belantamab Mafodotin in Europe (217240)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Greece

  Italy

  Norway

  Spain
• Study description:
  This multinational, multisite, non-interventional study aims to collect real-world data on the use, safety and effectiveness of belantamab mafodotin in RRMM patients from Europe. Background data at the time of the first dose of belantamab mafodotin (i.e., demographics, disease status, clinical characteristics and treatment history) will be collected to characterize RRMM patients treated with belantamab mafodotin per routine clinical care. In addition, data will be collected on the occurrence, duration and management of ocular AESIs, the frequency and timing of ophthalmic examinations, persistence and adherence with belantamab mafodotin, treatment discontinuations, interruptions/delays and decreased dosing, and effectiveness in terms of treatment response and survival.
• Study status:
  Ongoing

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 10/05/2021

Actual: 10/05/2021

Study start date

Planned: 05/09/2022

Actual: 05/09/2022

Data analysis start date

Planned: 01/03/2022

Date of final study report

Planned: 23/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

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