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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is patients who are eligible for "Indications" specified in the approved label.
[INDICATIONS] Elranatamab is indicated 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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Seoul | South Korea |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
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 |
| 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. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |