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ID06477783

Observational Study of Teclistamabs Effectiveness and Safety in Adults with Relapsed and Refractory Multiple Myeloma in Belgium

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-03-12

100

Participants Needed

17

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical effectiveness and safety of teclistamab Tecvayli4, an anti-BCMACD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma. The study focuses on those who have received at least three previous treatments and are refractory to key therapies including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. This prospective observational study aims to monitor real-life outcomes in Belgium. Participants will receive teclistamab as part of their routine clinical care. The study follows patients monthly for the first six months of treatment, then every three months until the study ends or until events such as disease progression, withdrawal, death, or loss to follow-up occur. Data collection will continue for up to 24 months, or two years, to observe treatment effects over time. During the study, patients will have regular assessments including response evaluations based on standardized criteria, survival monitoring, adverse event tracking, and minimal residual disease assessments when applicable. Researchers will measure outcomes such as overall response rate, progression-free survival, overall survival, depth and duration of response, and time to next treatment. This ongoing monitoring is designed to understand how teclistamab performs in everyday clinical practice.

CONDITIONS

Brief Title

Study on the Clinical Efficacy of Teclistamab

Research Team

M

Michel Delforge, MD, PhD

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