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Study on the Clinical Efficacy of Teclistamab

RECRUITINGSponsored by Universitaire Ziekenhuizen KU Leuven
Actively Recruiting
SponsorUniversitaire Ziekenhuizen KU Leuven
Started2024-12-01
Est. completion2027-09
Eligibility
Age18 Years+
Healthy vol.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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

CancerHematologic DiseasesMultiple Myeloma

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