Clinical trial · Observational
Study on the Clinical Efficacy of Teclistamab and Talquetamab
Prospective Observational Study on the Clinical Efficacy of Teclistamab and Talquetamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
NCT06477783CI-TRIAL-00087100BIONICrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The aim of this study is to assess the clinical efficacy of the anti-BCMA/CD3 bispecific antibody teclistamab and anti-GPRC5D/CD3 bispecific antibody talquetamab in a prospective, real-life setting in Belgium.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teclistamab | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Relapsed or refractory multiple myeloma patients
- description
- Patients aged 18 years or older diagnosed with relapsed or refractory multiple myeloma, who received at least 3 prior lines of treatment. They should be refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody. After confirmation of disease progression, the patients will start treatment with teclistamab per routine clinical care or will have started with teclistamab or talquetamab treatment ≤28 days before intended screening visit
- interventionNames
- Drug: Teclistamab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- At baseline, monthly until end of study (maximum 24 months)
- description
- The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.