Clinical trial NCT06062537: Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients
Official title: Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Keywords: teclistamab
refractory multiple myeloma
real word evidence study
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2023-10-02
Enrollment: 200
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: French adult patient relapsed and refractory multiple myeloma receving teclistamab

Brief summary: 200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion Criteria:

* Patients alive at the start of the study who did not receive study information or who objected to the collection of data
* Patients who received teclistamab as part of an interventional clinical trial
* Patients who are initiating teclistamab as part of a current interventional clinical trial

Primary outcomes:
measure: overall response rate (ORR) of teclistamab according to IMWG criteria
timeFrame: 6 months
measure: overall response rate (ORR) of teclistamab according to IMWG criteria
timeFrame: 24 months
Secondary outcomes:
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Effectiveness of teclistamab
timeFrame: 24 months
measure: Adverse events of interest
timeFrame: 24 months
measure: Conditions of use
timeFrame: 1 month
measure: Conditions of use
timeFrame: 24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Annecy
country: France
facility: CH d'ANNECY
city: Argenteuil
country: France
facility: Centre hospitalier d'Argenteuil
city: Bayonne
country: France
facility: Hopital de la cote Basque
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brive-la-Gaillarde
country: France
facility: Centre hospitalier de Brive-la-Gaillarde
city: Caen
country: France
facility: CHU CAEN
city: Chambéry
country: France
facility: Centre hospitalier Métropole de Savoie
city: Clermont Ferrand
country: France
facility: CHU Clermont-Ferrand Site Estaing
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: Chu Dijon
city: Dunkerque
country: France
facility: CH Dunkerque
city: Lille
country: France
facility: CHU de Lille
city: Lorient
country: France
facility: Groupe hospitalier Bretagne Sud
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Metz
country: France
facility: CH de METZ
city: Montpellier
country: France
facility: CHU Saint-Eloi - CHU de Montpellier
city: Nantes
country: France
facility: Chu de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Hopital saint louis
city: Perpignan
country: France
facility: CH Perpignan
city: Pontoise
country: France
facility: Hopital Novo
city: Rennes
country: France
facility: Chu de Rennes
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne
city: Strasbourg
country: France
facility: Institut de Cancérologie Strasbourg Europe
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Vannes
country: France
facility: CH Bretagne Atlantique
Study officials:
References: