Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

Sponsor
Pfizer
Study ID
NCT06581848
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 5, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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 Measure

Incidence of an adverse event (AE)/ adverse drug reaction (ADR) [ Time Frame: At least 28 days from the last dose of Elranatamab ]

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