Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients
TEC-CARE
1 other identifier
observational
200
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2023
CompletedFirst Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 13, 2026
April 1, 2026
3.2 years
September 22, 2023
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
overall response rate (ORR) of teclistamab according to IMWG criteria
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
6 months
overall response rate (ORR) of teclistamab according to IMWG criteria
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
24 months
Secondary Outcomes (10)
Effectiveness of teclistamab
24 months
Effectiveness of teclistamab
24 months
Effectiveness of teclistamab
24 months
Effectiveness of teclistamab
24 months
Effectiveness of teclistamab
24 months
- +5 more secondary outcomes
Eligibility Criteria
French adult patient relapsed and refractory multiple myeloma receving teclistamab
You may qualify if:
- Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intergroupe Francophone du Myelomelead
- Janssen-Cilag Ltd.collaborator
Study Sites (31)
CHU Amiens Picardie
Amiens, France
CH d'ANNECY
Annecy, France
Centre hospitalier d'Argenteuil
Argenteuil, France
Hopital de la cote Basque
Bayonne, France
CHU de Besançon
Besançon, France
CHU Bordeaux
Bordeaux, 31400, France
Centre hospitalier de Brive-la-Gaillarde
Brive-la-Gaillarde, France
CHU CAEN
Caen, France
Centre hospitalier Métropole de Savoie
Chambéry, France
CHU Clermont-Ferrand Site Estaing
Clermont-Ferrand, France
CHU Henri Mondor
Créteil, France
Chu Dijon
Dijon, France
CH Dunkerque
Dunkirk, France
CHU de Lille
Lille, France
Groupe hospitalier Bretagne Sud
Lorient, France
Institut Paoli Calmette
Marseille, France
CH de METZ
Metz, France
CHU Saint-Eloi - CHU de Montpellier
Montpellier, France
Chu de Nantes
Nantes, France
CHU de Nice
Nice, France
Hopital Necker
Paris, France
Hopital saint louis
Paris, France
CH Perpignan
Perpignan, France
Hopital Novo
Pontoise, France
Chu de Rennes
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne
Saint-Priest-en-Jarez, France
Hopital de Hautepierre
Strasbourg, France
CHU Toulouse
Toulouse, France
CHU de Tours
Tours, France
CH Bretagne Atlantique
Vannes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
October 2, 2023
Study Start
September 19, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04