Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Sponsor: Pfizer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of an adverse event (AE)/ adverse drug reaction (ADR)
Time frame: At least 28 days from the last dose of Elranatamab
Incidence of a serious AE (SAE)/ serious ADR (SADR)
Time frame: At least 28 days from the last dose of Elranatamab
Incidence of an unexpected AE (UAE)/ unexpected ADR (UADR)
Time frame: At least 28 days from the last dose of Elranatamab
Incidence of a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
Time frame: At least 28 days from the last dose of Elranatamab
Secondary Endpoints
Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator
Progression-free survival (PFS) per IMWG response criteria as determined by investigator
Time to response (TTR) per IMWG response criteria as determined by investigator
Eligibility Criteria
Inclusion Criteria: * Patients who have been prescribed ELREXFIO (Elranatamab) by their physician as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. * Patients with evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Patients with contraindication according to locally approved label of ELREXFIO (Elranatamab) * Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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