- 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
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