Study on the Clinical Efficacy of Teclistamab

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06477783
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Mar 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Relapsed or refractory multiple myeloma patients
    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

Primary Outcome Measure

Overall response rate [ Time Frame: At baseline, monthly until end of study (maximum 24 months) ]

Central Contacts

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