Trial Title:
Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients
NCT ID:
NCT06062537
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
teclistamab
refractory multiple myeloma
real word evidence study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
French adult patient relapsed and refractory multiple myeloma receving teclistamab
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CH d'ANNECY
Address:
City:
Annecy
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frederique ORSINI-PIOCELLE
Facility:
Name:
Hopital de la cote Basque
Address:
City:
Bayonne
Country:
France
Status:
Recruiting
Contact:
Last name:
Julie GAY, MD
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Zip:
31400
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cyrille HULIN, MD
Investigator:
Last name:
Titouan CAZAUBIEL, dr
Email:
Sub-Investigator
Facility:
Name:
CHU CAEN
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Margaret MACRO, MD
Facility:
Name:
Chu Dijon
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Andréa PIERAGOSTINI
Facility:
Name:
CH Dunkerque
Address:
City:
Dunkerque
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Helene DEMARQUETTE, MD
Facility:
Name:
CHU de Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Salomon MANIER, MD, PHD
Facility:
Name:
CHU de Lyon
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lionel KARLIN, MD
Facility:
Name:
Institut Paoli Calmette
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Marc SCHIANO DE COLELLA, MD
Facility:
Name:
CH de METZ
Address:
City:
Metz
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Véronique Dorvaux, MD
Facility:
Name:
Chu de Nantes
Address:
City:
Nantes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cyrille TOUZEAU, MD, PHD
Facility:
Name:
CHU de Nice
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Valentine RICHEZ-OLIVIER, MD
Facility:
Name:
Hopital Necker
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
FRENZEL Laurent, MD
Facility:
Name:
Hopital saint louis
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Bertrand ARNULF, MD
Facility:
Name:
CH Perpignan
Address:
City:
Perpignan
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Virginie ROLLAND, MD
Facility:
Name:
Hopital Novo
Address:
City:
Pontoise
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Riad BENRALMDANE, MD
Facility:
Name:
Chu de Rennes
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier DECAUX, MD. PHD
Facility:
Name:
CHU Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurore PERROT, MD; PHD
Investigator:
Last name:
Aurore PERROT, PR
Email:
Principal Investigator
Facility:
Name:
CHU de Tours
Address:
City:
Tours
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thomas CHALOPIN, MD
Facility:
Name:
CH Bretagne Atlantique
Address:
City:
Vannes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Brieuc CHEREL, MD
Start date:
September 19, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Intergroupe Francophone du Myelome
Agency class:
Other
Collaborator:
Agency:
Janssen-Cilag Ltd.
Agency class:
Industry
Source:
Intergroupe Francophone du Myelome
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06062537
