Clinical trial · Observational
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
NCT06581848CI-TRIAL-00097815active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elranatamab | Drug | Elranatamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Elranatamab
Primary outcomes (5)
- measure
- Incidence of an adverse event (AE)/ adverse drug reaction (ADR)
- timeFrame
- At least 28 days from the last dose of Elranatamab
- description
- The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing AE and ADR will be summarized with the 95% CIs in addition to their occurrence frequencies.
- measure
- Incidence of a serious AE (SAE)/ serious ADR (SADR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.