Etude : MEDICI / H20-126



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : MEDICI / H20-126

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.

Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.

Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

Current primary outcome:
- Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells [ Time Frame: Up to approximately 2.5 months following last subject last visit ]

Current secondary outcomes:
- Percentage of Participants Achieving Stability of t(11;14) Status [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants Achieving Stability of BCL2 Status [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With t(11;14) Status of MM Samples [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With BCL2 Status of MM Samples [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With t(1;14) Status and BCL2 Status [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy [ Time Frame: Up to approximately 2.5 months following last subject last visit ]
- Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy [ Time Frame: Up to approximately 2.5 months following last subject last visit ]

Phase : NA

Stade : NA

1 (hémato), Rechute, Réfractaire
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 : - Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.

Critères de non-inclusion : - Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04721002
Promoteur :
ABBVIE
Type de sponsor : Industriel
ABBVIE
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 :
Docteur Salomon Manier

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

Statut de l'essai : OUVERT

MAJ : 09/07/2021