Study on the Clinical Efficacy of Teclistamab

Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium

The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.

To assess the clinical efficacy and safety of teclistamab (Tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (Tecvayli®) as the next treatment. Patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. Then, data will be collected every 3 months until the end of study.

Inclusion Criteria:

• Age 18 years or older
• Written informed consent
• Has a diagnosis of relapsed and refractory multiple myeloma
• Has already received at least three previous treatments
• Is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody
• Evidence of disease progression on the last line of therapy, based on determination of response by the IMWG response criteria
• Anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit

Exclusion Criteria:

• Has participated in a teclistamab trial (teclistamab or control arm) or teclistamab Single Patient Request (SPR) program
• Has started teclistamab treatment >14 days before intended screening visit.