An International, Multicenter, Non-interventional Post-Authorization Safety Study to Evaluate the Effectiveness and Safety of Elranatamab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) treated in Real-World Settings (MagnetisMM-16)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

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:
  340

Study design details

• Main study objective:
  To evaluate the effectiveness of elranatamab through the collection and analysis of the following clinical outcomes (defined according to the IMWG consensus criteria for response and minimal residual disease assessment in MM): Overall response rate (ORR), Time to response (TTR), Duration of response (DOR), Progression free survival (PFS), Overall survival (OS), Time to next treatment (TTNT).
• Outcomes:
  Effectiveness outcomes include ORR, TTR, DOR, PFS, and OS according to the IMWG consensus criteria for response in MM. TTNT will be defined as the time from elranatamab initiation to next treatment. Safety event will be collected, reported and summarized by the enrolling physician or other treatment team member for up to 90 days after the last dose of elranatamab.
• Data analysis plan:
  The characteristics captured during baseline and follow up will be summarized using descriptive statistics. Frequencies and percentages will be used for categorical variables and mean (standard deviation STD) and median (interquartile range IQR) will be used for continuous variables. For the effectiveness outcomes of interest, ORR will be summarized using frequencies and percentages and time-to-event outcomes (DOR, TTR, PFS, OS, TTNT) will be evaluated using Kaplan-Meier (KM) methods. KM curves will be illustrated and the median survival and corresponding 95% confidence interval (95% CI) will be computed. To evaluate the safety of elranatamab, AEs and SAEs will be collected on a structured data collection tool Adverse Event Monitoring (AEM) form and will be characterized by type, grade, timing, seriousness, and relationship to elranatamab. Crude cumulative incidence will be calculated as appropriate.