NCT06477783

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Multiple Myeloma
• Hematologic Diseases

Interventions

Type	Name	Description
DRUG	Teclistamab	Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-06-27
• Last updated: 2025-03-12

Locations

17 sites across 1 country: Belgium

Regulatory

• FDA-regulated drug study