Clinical trial NCT06581848: Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Official title: Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Elranatamab
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of an adverse event (AE)/ adverse drug reaction (ADR)
timeFrame: At least 28 days from the last dose of Elranatamab
measure: Incidence of a serious AE (SAE)/ serious ADR (SADR)
timeFrame: At least 28 days from the last dose of Elranatamab
measure: Incidence of an unexpected AE (UAE)/ unexpected ADR (UADR)
timeFrame: At least 28 days from the last dose of Elranatamab
measure: Incidence of a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
timeFrame: At least 28 days from the last dose of Elranatamab
measure: Incidence of an adverse event special interest (AESI)
timeFrame: At least 28 days from the last dose of Elranatamab
Secondary outcomes:
measure: Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator
timeFrame: 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.
measure: Progression-free survival (PFS) per IMWG response criteria as determined by investigator
timeFrame: 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.
measure: Time to response (TTR) per IMWG response criteria as determined by investigator
timeFrame: From the first dose of the study drug to the first documentation of response that is subsequently confirmed, assessed up to 72 months.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: