Postauthorization Safety Study Survey to Evaluate the Effectiveness of the Ciltacabtagene Autoleucel HCP Educational Program and the Product Handling Training

Study type

• Study topic:
  Other
• Study topic, other:
  RMP educational materials
• 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:
  Postauthorization Safety Study healthcare professional Survey

Study drug and medical condition

• Name of medicine:
  CARVYKTI
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XL05) ciltacabtagene autoleucel

  ciltacabtagene autoleucel

Population studied

• Short description of the study population:
  HCPs from the CAR-T centers certified by the sponsor for ciltacabtagene autoleucel treatment will be invited to participate in the survey: HCPs involved in the prescription and management (i.e., dispensing or administration) of ciltacabtagene autoleucel treatment. And also HCPs involved in the transport, storage, thawing, preparation, or handling of ciltacabtagene autoleucel.; All participants will be independently recruited through a third-party vendor. Participation in this survey will be completely voluntary. No patients will participate in the survey.;
• 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:
  220

Study design details

• Study design:
  A survey will be completed independently by CAR-T HCPs to measure the effectiveness of the educational materials relating to safe and effective use of ciltacel. HCPs can include physicians, pharmacists, nurses and ward staff from CAR-T centers certified by the sponsor.
• Main study objective:
  To measure the effectiveness of the HCP Educational Program, an additional risk minimization measure intended to increase awareness about the risk of CRS and neurologic toxicity; the potential risk of cell viability; and the HCP awareness of the patient CAR-T Journey Guide with its enclosed Patient.
• Setting:
  NA
• Comparators:
  NA
• Outcomes:
  The key messages to be tested by the survey include but are not limited to messages about prescription and management of ciltacabtagene autoleucel. For CRS management, participants will be referred to the CRS management table in the SmPC. Additionally, key messages about transport, storage, thawing, preparation, or handling of ciltacabtagene autoleucel will carry a heavier weight for the results for HCPs involved in these processes (i.e., pharmacists and ward staff).;
• Data analysis plan:
  A minimum total score of ≥80% across all survey questions will be considered indicative of satisfactory effectiveness. This threshold represents the ‘vast majority’ of correct responses and is consistent with the threshold in previous surveys of risk minimization measures conducted by the sponsor. Upon completion of the survey by the required number of sample respondents, responses will be aggregated and tabulated. Summary results for the overall achievement of a satisfactory effectiveness score and 95% Clopper-Pearson (exact) CI will be presented for absolute numbers of respondents and percentages of the total sample. For each question, the proportion of respondents answering it correctly will also be presented. ;