Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Elranatamab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Multiple myeloma; Elranatamab
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: C1071029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No