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NCT06581848 | NOT YET RECRUITING | Multiple Myeloma

Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Sponsor:

Pfizer

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.

Condition or disease

Multiple Myeloma

Intervention/treatment

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
Estimated Enrollment : 150 participants
Official Title : Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2030-05-29
Estimated Study Completion Date : 2030-05-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

Location Details

NCT06581848

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of,

Pfizer Korea

Seoul, Korea, Republic of,