Panobinostat Post Authorization Safety Study, a non-interventional study of panobinostat in combination with bortezomib and dexamethasone in patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional Post Authorization Safety Study

Study drug and medical condition

• Name of medicine:
  FARYDAK
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  The target population includes adult patients with a diagnosis of Relapsed and/or Refractory Multiple Myeloma.; Any patients irrespective of age, previous treatment, ECOG status, living in one of the EEA countries can be entered in the protocol as soon as they have received at least one dose of panobinostat and treated according to the EU SmPC.; Patients were eligible if they meet the following criteria:; Inclusion criteria; 1. Patients diagnosed with Relapsed and/or Refractory Multiple Myeloma; 2. Patients have a new or ongoing treatment with a regimen of PAN+BTZ+DEX according to the EU approved SmPC.; 3. Patients were eligible to enter the study at any time during the first 12 cycles and no later than day 1 of cycle 13.; Exclusion criteria; 1. Patients not providing informed consent; 2. Patients participating concurrently in an investigational study involving panobinostat or another anti-myeloma drug.
• 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)
• Special population of interest:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  425

Study design details

• Main study objective:
  Primary objective 1:collect safety data in patients with relapsed and/or refractory multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone in a realworldsetting, according to the current EU prescribing information 2: Document the adherence to the dosing regimen (including the dosing card, blister pack)
• Outcomes:
  The proportions of patients with AEs/SAEs, discontinuation due to AE, and on-treatment deaths will be provided.Counts, and proportions of patients with medication errors (i.e. dose omission and improper dose (underdose, overdose, and extradose) will be provided
• Data analysis plan:
  No statistical hypotheses will be tested in this study.