Etude : MIROIR /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : MIROIR

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 23/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

study group: Imnovid
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice

Current primary outcome:
Progression Free Survival (PFS) [ Time Frame: Up to approximately 6 months ]
Is defined as the time between the date of treatment initiation with pomalidomide and the date of the first progression according to the International Myeloma Working Group (IMWG) criteria or death whatever the cause.

Current secondary outcomes:
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
Is defined by at least a partial response (PR) according to IMWG criteria
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]
Is calculated for responders with at least partial response (PR) as the time between the first observation of response and the time of the first event such as disease progression or death due to progression.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]
Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.
- Time to Progression (TTP) [ Time Frame: Up to 2 years ]
Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.
- Time to Treatment Failure (TTF) [ Time Frame: Up to 2 Years ]
Is defined as the duration between the date of the start of pomalidomide treatment and the first progression according to IMWG criteria, second cancer, toxicity requiring treatment discontinuation or death of the patient.
- Adverse Events (AEs) [ Time Frame: Up to 3 years ]
Number of subjects with adverse events

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Adult patient (age ≥ 18 yrs),
- Diagnosed with multiple myeloma (measurable or not),
- In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2017,
- Patient already included in the Imnovid registry,
- Having received oral and written information about the study, and having given their consent to participate.

Critères de non-inclusion : - Previous participation in a clinical trial with pomalidomide,
- Treatment with pomalidomide in a previous line,
- Simultaneous participation in a clinical trial.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02902900
Promoteur :
CELGENE
Type de sponsor : Industriel
United States – Summit, NJ 86 Morris Avenue Summit, NJ 07901
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Thierry FACON

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 25/07/2019

Centre investigateur :
Centre hospitalier de Dunkerque - 130, avenue Louis Herbeaux - CS 76367 - 59140 DUNKERQUE

Investigateur :
Docteur Marc WETTERWALD

TEC / ARC / IDE :
Viginie EL AZOUZI - PAQUEZ
Virginie.Paquez@
ch-dunkerque.fr
03 28 28 59 00 poste 6485

Ouverture de l'essai : OUVERT

MAJ : 28/08/2019

Centre investigateur :
Centre Hospitalier de Valenciennes - Avenue Désandrouin - CS 50479 - 59300 VALENCIENNES

Investigateur :
Docteur Sabine TRICOT

TEC / ARC / IDE :
Marielle FERY
fery-m@
ch-valenciennes.fr
03 27 14 07 15

Ouverture de l'essai : OUVERT

MAJ : 23/10/2019