RecruitingNCT06477783
Study on the Clinical Efficacy of Teclistamab
Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
100 participants
Start Date
Dec 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria2
- 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.
Interventions
DRUGTeclistamab
Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06477783
Related Trials
Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
NCT0617988873 locations
Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma
NCT068761421 location
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
NCT0725851133 locations
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
NCT050924511 location
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
NCT02693535166 locations