Study on the Clinical Efficacy of Teclistamab and Talquetamab
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
100 patients with relapsed or refractory multiple myelome who will be treated with teclistamab or talquetamab
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Teclistamab
DrugIntervention is part of standard clinical care, as teclistamab and talquetamab are reimbursed for this group of patients.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Relapsed or refractory multiple myeloma patients1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate
The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.
Time frame
At baseline, monthly until end of study (maximum 24 months)Secondary outcomes
1
Progression-free survival (PFS)
The length of time during and after the treatment during which a patient lives with the disease but it does not get worse.
Time frame
At baseline, monthly until end of study (maximum 24 months)2
Overall survival (OS)
Duration of time between start of the treatment and up to the time of death.
Time frame
At baseline, monthly until end of study (maximum 24 months)3
Incidence of (serious) adverse events
Incidence and severity of (serious) adverse events with with focus on hematological AE's (≥ grade 3), cytokine release syndrome (CRS) rate, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections (≥ grade 2) and serious adverse events related to teclistamab/talquetamab.
Time frame
At baseline, monthly until end of study (maximum 24 months)4
Depth of response
Evaluation of response in terms of depth. Assessment of response according to the 2016 IMWG response criteria of Multiple myeloma.
Time frame
At baseline, monthly until end of study (maximum 24 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Janssen Pharmaceutica
Collaborator
Source ClinicalTrials.gov