Study on the Clinical Efficacy of Teclistamab (TECTONIC)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Multiple Myeloma; Hematologic Diseases

Treatments: Drug: Teclistamab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06477783

64007957MMY4010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Relapsed or refractory multiple myeloma patients

Description:

Patients aged 18 years or older diagnosed with relapsed or refractory multiple myeloma, who received at least 3 prior lines of treatment. They should be refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody. After confirmation of disease progression, the patients will start treatment with teclistamab per routine clinical care or will have started with teclistamab treatment ≤14 days before intended screening visit

Treatment:

Drug: Teclistamab