Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
- Registration Number
- NCT06581848
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
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.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elranatamab Elranatamab Patients who have been prescribed 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.
- Primary Outcome Measures
Name Time Method Incidence of an adverse event (AE)/ adverse drug reaction (ADR) At least 28 days from the last dose of Elranatamab 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.Incidence of a serious AE (SAE)/ serious ADR (SADR) At least 28 days from the last dose of Elranatamab 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.Incidence of an unexpected AE (UAE)/ unexpected ADR (UADR) At least 28 days from the last dose of Elranatamab 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.Incidence of a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) At least 28 days from the last dose of Elranatamab 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.Incidence of an adverse event special interest (AESI) At least 28 days from the last dose of Elranatamab 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.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator 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. 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.Progression-free survival (PFS) per IMWG response criteria as determined by investigator 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. 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 to response (TTR) per IMWG response criteria as determined by investigator From the first dose of the study drug to the first documentation of response that is subsequently confirmed, assessed up to 72 months. 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.
Trial Locations
- Locations (1)
Pfizer Korea
🇰🇷Seoul, Korea, Republic of