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NCT04891809: Phase 2 - Isatuximab in Combination With Rd Compared to Rd in Elderly NDMM

Updated: May 24

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

 

Isatuximab

Lenaliodomide (R)

Dexamethasone (d)

 

Drug: Isatuximab-Irfc 20 MG/ML [Sarclisa]

Drug: Lenalidomide

Drug: Dexamethasone Oral

 

Location

Europe

Austria






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