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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Ocular safety, Patient characterization (demographic, clinical, treatment history)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BLENREP
• Study drug International non-proprietary name (INN) or common name:
  BELANTAMAB MAFODOTIN
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The purpose of this study is to collect real-world data on the use, safety and effectiveness of belantamab mafodotin in RRMM patients in Europe.
• Outcomes:
  Characterize RRMM patients treated with belantamab mafodotin per routine clinical care in terms of demographics, disease status, clinical characteristics and treatment history (overall and by line of treatment), Characterize patients with ocular AESI by belantamab mafodotin treatment, ophthalmic disease history & ocular AESI type, duration & severity (overall and by line of treatment), Describe frequency & timing of ophthalmic monitoring visits relative to belantamab mafodotin administration (for each cycle, overall & by line of treatment occurrence of ocular AESI as well as treatment dose & frequency).
• Data analysis plan:
  Analysis populations: ; Two analysis populations will be defined: ; • Enrolled Population (EP); - All patients for whom written informed consent has been obtained, ; • Safety Population (SP); - All patients in EP who received at least one dose of belantamab mafodotin. ; ; The SP will be used for descriptive, safety & effectiveness analyses. ; ; Data analysis: ; The following measures will be reported: ; • Exposure-adjusted incidence & event rates with 95% confidence intervals of ocular AESIs (i.e. at patient level & event level): overall & by SOC & PT terms (MedDRA classification). ; • Median, 95% confidence intervals (CIs) and 25th & 75th percentiles using Kaplan-Meier (KM) method for time to event outcomes (i.e. OS, rwPFS, DoR, time to discontinuation, time to first specific ocular AESI) ; • OS rates with 95% CIs at specified time points, including 12- & 15-months of follow-up ; • Overall response rate (ORR) with 95% CIs calculated based on exact binomial distribution (Clopper-Pearson method).