Study on the Clinical Efficacy of Teclistamab

Recruiting

• Conditions: Multiple Myeloma; Hematologic Diseases
• Interventions: Drug: Teclistamab

• Registration Number: NCT06477783
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-06-27
• Study Start: 2024-12-01
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age 18 years or older
• written informed consent
• has a diagnosis of relapsed and refractory multiple myeloma
• received at least three prior lines of therapy
• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed or refractory multiple myeloma patients	Teclistamab	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 treatment ≤14 days before intended screening visit

Primary Outcome Measures

Name	Time	Method
Overall response rate	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	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.
Depth of response	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.
Duration of response	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 to next treatment (TTNT)	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.
Incidence of (serious) adverse events	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®).
Progression-free survival (PFS)	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 to response (TTR)	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.
Minimal Residual Disease (MRD) assessment	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).

Trial Locations

Locations (17)

Imelda; 🇧🇪 Bonheiden, Antwerpen, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Henegouwen, Belgium

EpiCURA; 🇧🇪 Hornu, Henegouwen, Belgium

CHU Ambroise Paré; 🇧🇪 Mons, Henegouwen, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Limburg, Belgium

CHU UCL Namur; 🇧🇪 Yvoir, Namur, Belgium

Universitair Ziekenhuis Antwerpen (UZA); 🇧🇪 Edegem, Antwerpen, Belgium

Institut Jules Bordet; 🇧🇪 Brussel, Vlaams-Brabant, Belgium

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

CHR Citadelle; 🇧🇪 Liège, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

Algemeen Ziekenhuis Maria Middelares (AZMM); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Gent (UZ Gent); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UCL Saint Luc; 🇧🇪 Brussel, Vlaams-Brabant, Belgium

AZ Delta; 🇧🇪 Roeselare, West-Vlaanderen, Belgium

Vitaz; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, West-Vlaanderen, Belgium