Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

Pfizer

Status: Begins enrollment this month

Conditions: Multiple Myeloma

Treatments: Drug: Elranatamab

Study type: Observational

Funder types: Industry

Identifiers

NCT06581848

C1071029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Elranatamab

Description:

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.

Treatment:

Drug: Elranatamab