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  • Active, not recruiting

NCT03104842: Phase 2 - GMMG - CONCEPT - Eval. iNduction, Consol. & Maint. Isatuximab Carf Len. & Dex

Updated: May 19, 2022


GMMG - The German Speaking Myeloma Multicenter Group

GMMG-CONCEPT trial

Isa-KRd

gmmg-concept-myeloma trial

NCT03104842: Phase 2 - Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone


A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients


Sponsor:

Universitätsklinikum Hamburg-Eppendorf


Multiple Locations


ClinicalTrials.gov Identifier: NCT03104842

Official Title: Clinical Phase II, Multicenter, Open-label Study Evaluating iNduction, Consolidation and Maintenance With Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary Diagnosed High-risk Multiple Myeloma paTients


 

Drug: Isatuximab

Drug: Carfilzomib

Drug: Lenalidomide

Drug: Dexamethasone

 

Depth of response to isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: Interim analysis of the GMMG-CONCEPT trial.

Journal of Clinical Oncology

2020 ASCO Annual Meeting

Conclusions: To the best of our knowledge, we report for the first time on a trial investigating solely HR NDMM and Isa-KRd quadruplet treatment. Isa-KRd induction induces deep responses in HR MM pts. The overall safety profile of Isa-KRd is expected and consistent with previous reports. The study is ongoing, with pts continuing to be included


Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial

Leukemia; 2021



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