Symptom Online Monitoring (SYMON)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Quality of Life

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX15) belantamab mafodotin

  belantamab mafodotin

Population studied

• 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)
• Estimated number of subjects:
  25

Study design details

• Main study objective:
  We propose that patients’ treatment of relapsed refractory Multiple Myeloma (RRMM) with Belantamab-Mafodotin (BM) can be optimized using an individualized web-based symptom control and side effects management tool, focusing, but not exclusively, on ocular complaints.
• Data analysis plan:
  We propose the setup of a patient portal to monitor patients HRQOL and, more specifically, their ocular symptoms during treatment with BM. The patient portal will be based on the Computer-based Health Evaluation Software (CHES), which is currently the software basis for the AMR. All eligible patients will be given access to the patient portal and asked to complete regularly scheduled PROs. For this proposal, the AMR can capitalize from existing projects and scientific expertise, which have been completed and collected in the past: The implementation of PROs in the AMR have been previously described by Sztankay and colleagues 14. The study showed the high level of integration of electronic PROs in the registry and the minimal addition to HCPs workload. The usage of ePROs for screening purposes (psycho-oncological screening) have also been described by Lehmann and colleagues 15. Finally, the current configuration of the patient portal have also been evaluated 16.