Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Elranatamab
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. 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.
Interventions
DRUGElranatamab
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed