Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
NCT Number: NCT06581848
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Interventions: DRUG: Elranatamab
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-31
Completion Date: 2030-01-31
Locations: Pfizer Korea, Seoul, Korea, Republic of

Summary:
This study is to assess the safety and effectiveness of Elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in Korea.

Primary Outcome Measures: Incidence of an adverse event (AE)/ adverse drug reaction (ADR), The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation.

The numbers and proportions of patients experiencing AE and ADR will be summarized with the 95% CIs in addition to their occurrence frequencies., At least 28 days from the last dose of Elranatamab|Incidence of a serious AE (SAE)/ serious ADR (SADR), The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation.

The numbers and proportions of patients experiencing SAE and SADR will be summarized with the 95% CIs in addition to their occurrence frequencies., At least 28 days from the last dose of Elranatamab|Incidence of an unexpected AE (UAE)/ unexpected ADR (UADR), The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation.

The numbers and proportions of patients experiencing UAE and UADR will be summarized with the 95% CIs in addition to their occurrence frequencies., At least 28 days from the last dose of Elranatamab|Incidence of a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR), The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation.

The numbers and proportions of patients experiencing SUAE and SUADR will be summarized with the 95% CIs in addition to their occurrence frequencies., At least 28 days from the last dose of Elranatamab|Incidence of an adverse event special interest (AESI), The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation.

The numbers and proportions of patients experiencing AESI will be summarized with the 95% CIs in addition to their occurrence frequencies., At least 28 days from the last dose of Elranatamab
Secondary Outcome Measures: Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator, The effectiveness analysis population will consist of a subset of the safety analysis population that captured at least one follow-up effectiveness assessment.

Objective Response will encompass confirmed sCR, CR, VGPR and PR. ORR is defined as the proportion of patients with an objective response per IMWG criteria., From the first dose of the study drug until completion or discontinuation of the study or death due to any cause, whichever occurs first, assessed up to 72 months.|Progression-free survival (PFS) per IMWG response criteria as determined by investigator, The effectiveness analysis population will consist of a subset of the safety analysis population that captured at least one follow-up effectiveness assessment.

PFS is defined as the time from the first dose of the study drug until confirmed PD per IMWG criteria or death due to any cause, whichever occurs first., From the first dose of the study drug until confirmed Progressive Disease per IMWG criteria or death due to any cause, whichever occurs first, assessed up to 72 months.|Time to response (TTR) per IMWG response criteria as determined by investigator, The effectiveness analysis population will consist of a subset of the safety analysis population that captured at least one follow-up effectiveness assessment.

TTR is defined, for patients with an objective response per IMWG criteria, as the time from the date of first dose of ELREXFIO to the first documentation of response that is subsequently confirmed., From the first dose of the study drug to the first documentation of response that is subsequently confirmed, assessed up to 72 months.