Assessing the effectiveness of teclistamab for multiple myeloma
Official title: Prospective Observational Study on the Clinical Efficacy of Teclistamab and Talquetamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Run by Universitaire Ziekenhuizen KU Leuven · NCT06477783 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | teclistamab, talquetamab |
| Locations | 17 sites (Bonheiden, Antwerpen and 16 other locations) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06477783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar bispecific antibody approaches in treating multiple myeloma, suggesting potential for success in this study.
Who can join: the full rules
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 or talquetamab per routine clinical care or has started with teclistamab treatment ≤28 days before intended screening visit Exclusion Criteria: * Has started teclistamab or talquetamab treatment \>28 days before intended screening visit. * Inability or unwillingness to comply with the study protocol, including scheduled visits, treatment plans, or follow-up requirements.
Where it's running
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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
Show 11 more locations
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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 -
Imelda
Bonheiden, Antwerpen, Belgium Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using bispecific T-cell redirectors for first-line treatment in transplant-eligible multiple myeloma patients
This study is testing if a new combination of treatments can help newly diagnosed multiple myeloma patients who are eligible for a stem cell transplant feel better and improve their outcomes.
-
Combination treatment for high-risk smoldering multiple myeloma
This study is testing two different combination treatments to see which one helps people with high-risk smoldering multiple myeloma delay their disease from getting worse.
-
Outpatient treatment for multiple myeloma using teclistamab or talquetamab
This study is testing if two new treatments, teclistamab and talquetamab, can safely help adults with relapsed or hard-to-treat multiple myeloma when given as outpatient care.
-
Combination treatment for newly diagnosed multiple myeloma patients
This study is testing a new combination treatment for people with newly diagnosed multiple myeloma to see if it can be a safer and more effective alternative to traditional high-dose therapy and stem cell transplants.
-
Combining teclistamab and talquetamab with daratumumab and lenalidomide for newly diagnosed multiple myeloma
This study is testing two new treatment combinations for people with newly diagnosed multiple myeloma to see if they work better than the standard treatment.
-
Infliximab to Help Prevent CRS During Teclistamab or Talquetamab Therapy in Relapsed/Refractory Myeloma
This phase 2 trial tests whether infliximab can prevent cytokine release syndrome in patients with relapsed or refractory multiple myeloma who are being treated with teclistamab or talquetamab.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.