Study on the Clinical Efficacy of Teclistamab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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

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Multiple Myeloma Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Teclistamab

Intervention Type DRUG

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

Interventions

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Teclistamab

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

Intervention Type DRUG

Other Intervention Names

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Tecvayli

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No