NCT06581848

Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-05
• Primary completion: 2030-01-31
• Completion: 2030-01-31
• First posted: 2024-09-03
• Last updated: 2025-11-24

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study