NCT04891809: Phase 2 - Isatuximab in Combination With Rd Compared to Rd in Elderly NDMM
Updated: May 24, 2022
NCT04891809: Phase 2 - Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM
As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. ln sum, a clear and clinically highly relevant benefit is expected with the isatuximab-based triple combination compared to the standard Rd doublet.
Location
Austria
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
University of Navarra
Medical University of Vienna
Assign Data Management and Biostatistics GmbH
WiSP GmbH
Sanofi
ClinicalTrials.gov Identifier: NCT04891809
Official Title: Isatuximab in Combination With Lenalidomide-Dexamethasone Compared to Lenalidomide-Dexamethasone in Elderly Patients (Aged ≥70 Years) With Newly Diagnosed Myeloma: a Randomized Phase II Study (SGZ-2019-12650)
First Posted: May 18, 2021
Click here for details on ClinicalTrials.gov
Drug: Isatuximab-Irfc 20 MG/ML [Sarclisa]
Drug: Lenalidomide
Drug: Dexamethasone Oral
Location
Europe
Austria