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Search / Trial NCT06477783

Study on the Clinical Efficacy of Teclistamab

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Teclistamab Tecvayli Hematology Efficacy Safety

ClinConnect Summary

This clinical trial is studying a new treatment called teclistamab (also known as Tecvayli®) for patients with a type of blood cancer called multiple myeloma. The goal is to see how effective and safe this treatment is in real-life situations, specifically in Belgium. The trial is currently looking for participants who are 18 years or older, have already tried at least three different treatments for their multiple myeloma, and whose disease has not responded to those treatments.

If you or a loved one meet these criteria and are interested in participating, you would need to give your written consent and may need to start treatment with teclistamab as part of your regular care. Participants can expect to be closely monitored throughout the study to assess how well the treatment works and to ensure their safety. It's important to note that people who have previously been part of a teclistamab trial or started the treatment more than 14 days before the screening visit are not eligible to join.

Gender

ALL

Eligibility criteria

  • 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.

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Liège, , Belgium

Liège, , Belgium

Hasselt, Limburg, Belgium

Kortrijk, West Vlaanderen, Belgium

Roeselare, West Vlaanderen, Belgium

Bonheiden, Antwerpen, Belgium

Mons, Henegouwen, Belgium

Yvoir, Namur, Belgium

Sint Niklaas, Oost Vlaanderen, Belgium

Edegem, Antwerpen, Belgium

Charleroi, Henegouwen, Belgium

Hornu, Henegouwen, Belgium

Gent, Oost Vlaanderen, Belgium

Gent, Oost Vlaanderen, Belgium

Brussel, Vlaams Brabant, Belgium

Brussel, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Michel Delforge, MD, PhD

Principal Investigator

UZ Leuven Gasthuisberg

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported