Clinical trial NCT06477783: Study on the Clinical Efficacy of Teclistamab
Official title: Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Hematologic Diseases
Keywords: Teclistamab
Tecvayli
Hematology
Efficacy
Safety
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica
First posted: 2024-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients with relapsed or refractory multiple myelome who will be treated with teclistamab (Tecvayli®)

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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Overall response rate
timeFrame: At baseline, monthly until end of study (maximum 24 months)
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Overall survival (OS)
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Incidence of (serious) adverse events
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Depth of response
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Time to response (TTR)
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Duration of response
timeFrame: At baseline, monthly until end of study (maximum 24 months)
measure: Minimal Residual Disease (MRD) assessment
timeFrame: At suspected CR, every 6 months thereafter until end of study (maximum 24 months)
measure: Time to next treatment (TTNT)
timeFrame: At baseline, monthly until end of study (maximum 24 months)
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda
state: Antwerpen
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
state: Antwerpen
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Henegouwen
city: Hornu
country: Belgium
facility: EpiCURA
state: Henegouwen
city: Mons
country: Belgium
facility: CHU Ambroise Paré
state: Henegouwen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Yvoir
country: Belgium
facility: CHU UCL Namur
state: Namur
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares (AZMM)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (UZ Gent)
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz
state: Oost-Vlaanderen
city: Brussel
country: Belgium
facility: Institut Jules Bordet
state: Vlaams-Brabant
city: Brussel
country: Belgium
facility: UCL Saint Luc
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
affiliation: UZ Leuven Gasthuisberg
name: Michel Delforge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: