Teclistamab
DrugIntervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.
Other names: Tecvayli
NCT Number: NCT06477783
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Imelda, Bonheiden, Antwerpen, Belgium
To assess the clinical efficacy and safety of teclistamab (Tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (Tecvayli®) as the next treatment. Patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. Then, data will be collected every 3 months until the end of study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.
Other names: Tecvayli
Time frame: At baseline, monthly until end of study (maximum 24 months)
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)
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)
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)
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 (Tecvayli®).
Time frame: At baseline, monthly until end of study (maximum 24 months)
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)
Assessment of the time it takes for a patient to achieve partial response (PR) or better.
Time frame: At baseline, monthly until end of study (maximum 24 months)
Assessment of the length of time during which a patient experiences a partial response (PR) or better. It is measure from the start of treatment until disease progression or death.
Time frame: At suspected CR, every 6 months thereafter until end of study (maximum 24 months)
Evaluation of treatment efficacy by monitoring for the presence of a small number of cancer cells that are left in the body. MRD assessment will be done with Next Gen Flow (NGF) or Next Gen Sequencing (NGS).
Time frame: At baseline, monthly until end of study (maximum 24 months)
Assessment of the time interval between initiation of treatment with Tecvayli® and commencement of the next line of therapy.
Contact information is provided by the study sponsor or research team.
Universitaire Ziekenhuizen KU Leuven
Other
Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Acronym: TECTONIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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