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.
This study is an open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Elranatamab in the real-world clinical setting in patients with multiple myeloma in Korea. During the study period within 2 years from the launch date, a whole case enrollment should be conduct according to the protocol. The objectives of this study are to determine safety and effectiveness with Elranatamab under conditions of general clinical practice, in compliance with the regulation of the MFDS. Therefore, this study was designed according to the PMS guidelines of the MFDS. The study population is patients who are eligible for "Indications" specified in the approved label. All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this Non-interventional study (NIS) is being conducted.
Study Type
OBSERVATIONAL
Enrollment
150
According to the approved label, the recommended doses are step-up doses of 12 mg on day 1 and 32 mg on day 4, followed by a full treatment dose of 76 mg weekly from week 2 to week 24. For patients who have received at least 24 weeks of treatment and have achieved a response, the dosing interval should transition to an every two week schedule.
Pfizer
Seoul, South Korea
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At least 28 days from the last dose of Elranatamab
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.
Time frame: 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.
Time frame: 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.
Time frame: From the first dose of the study drug to the first documentation of response that is subsequently confirmed, assessed up to 72 months.