Non-interventional Post-authorization Safety Study (PASS) of Patients Treated with Idecabtagene Vicleucel (ide-cel, BB2121) for Multiple Myeloma (MM) in the Postmarketing Setting (BB2121-MM-006)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ABECMA
• 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:
  1000

Study design details

• Main study objective:
  The main objective is to characterize the incidence and severity of selected adverse drug reactions (ADRs), as outlined in the Summary of Product Characteristics (SmPC), in participants treated with idecabtagene vicleucel (ide-cel) in the postmarketing setting and to monitor for potential clinically important adverse events that have not yet been identified as part of the ide-cel safety profile.
• Outcomes:
  • All secondary malignancies • Cytokine release syndrome (CRS) grade ≥ 3 • Neurotoxicity Grade ≥ 3 • Prolonged cytopenias • Pregnancy outcome • Other adverse events (AEs) considered related to idecabtagene vicleucel, • Overall survival (OS) • Progression-free survival (PFS)
• Data analysis plan:
  Results will be analyzed and reported descriptively and no formal hypothesis testing is carried out. Summary statistics will consist of the number and percentage of patients in each category for discrete variables, whereas for continuous variables the sample size, mean, median, standard deviation, minimum, and maximum will be given. For the primary safety endpoints, incidence proportions and incidence rates will be calculated with the appropriate time periods and methods, analyses will be carried out both with and without accounting for competing risks. For the secondary effectiveness endpoints, Kaplan-Meier estimates and curves will be generated.