NCT06477783 Study on the Clinical Efficacy of Teclistamab
| NCT ID | NCT06477783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Michel Delforge, MD, PhD
PRINCIPAL INVESTIGATOR
UZ Leuven Gasthuisberg
Frequently Asked Questions
Who can join the NCT06477783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06477783 currently recruiting?
Yes, NCT06477783 is actively recruiting participants. Contact the research team at michel.delforge@uzleuven.be for enrollment information.
Where is the NCT06477783 trial being conducted?
This trial is being conducted at Bonheiden, Belgium, Edegem, Belgium, Charleroi, Belgium, Hornu, Belgium and 11 additional locations.
Who is sponsoring the NCT06477783 clinical trial?
NCT06477783 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Michel Delforge, MD, PhD at UZ Leuven Gasthuisberg. The trial plans to enroll 100 participants.