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

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

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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

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Isatuximab

Lenaliodomide (R)

Dexamethasone (d)

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

Drug: Lenalidomide

Drug: Dexamethasone Oral

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Location

Europe

Austria