Assessing the effectiveness of teclistamab for multiple myeloma
Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Universitaire Ziekenhuizen KU Leuven · NCT06477783
This study is testing if teclistamab can help people with relapsed or hard-to-treat multiple myeloma who have already tried at least three other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Drugs / interventions | teclistamab |
| Locations | 17 sites (Bonheiden, Antwerpen and 16 other locations) |
| Trial ID | NCT06477783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical efficacy and safety of teclistamab (Tecvayli®) in patients with relapsed or refractory multiple myeloma who have undergone at least three prior treatments. Participants will be monitored in a real-life setting in Belgium for a duration of up to 24 months, with monthly follow-ups for the first six months and subsequent assessments every three months. The study will track patient responses and any adverse effects associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed and refractory multiple myeloma who have received at least three prior lines of treatment.
Not a fit: Patients who have previously participated in a teclistamab trial or have started teclistamab treatment more than 14 days before screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of teclistamab for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar bispecific antibody approaches in treating multiple myeloma, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bonheiden, Antwerpen and 16 other locations
- Imelda — Bonheiden, Antwerpen, Belgium (NOT_YET_RECRUITING)
- Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerpen, Belgium (RECRUITING)
- Grand Hôpital de Charleroi — Charleroi, Henegouwen, Belgium (RECRUITING)
- EpiCURA — Hornu, Henegouwen, Belgium (RECRUITING)
- CHU Ambroise Paré — Mons, Henegouwen, Belgium (RECRUITING)
- Jessa Ziekenhuis — Hasselt, Limburg, Belgium (RECRUITING)
- CHR Citadelle — Liège, Liège, Belgium (RECRUITING)
- CHU Liège — Liège, Liège, Belgium (RECRUITING)
- CHU UCL Namur — Yvoir, Namur, Belgium (RECRUITING)
- Algemeen Ziekenhuis Maria Middelares (AZMM) — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
- Universitair Ziekenhuis Gent (UZ Gent) — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
- Vitaz — Sint-Niklaas, Oost-Vlaanderen, Belgium (RECRUITING)
- Institut Jules Bordet — Brussels, Vlaams-Brabant, Belgium (RECRUITING)
- UCL Saint Luc — Brussels, Vlaams-Brabant, Belgium (RECRUITING)
- AZ Groeninge — Kortrijk, West-Vlaanderen, Belgium (RECRUITING)
- AZ Delta — Roeselare, West-Vlaanderen, Belgium (RECRUITING)
- UZ Leuven Gasthuisberg — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: Michel Delforge, MD, PhD — UZ Leuven Gasthuisberg
- Study coordinator: Michel Delforge, MD, PhD
- Email: michel.delforge@uzleuven.be
- Phone: +32 16 34 68 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Hematologic Diseases, Teclistamab, Tecvayli, Hematology, Efficacy, Safety