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Isatuximab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in high-risk smoldering multiple myeloma
2023-507419-37-00Phase 3Authorised
- Sponsor
- Sanofi
- Start
- Jun 2020
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Countries
- 22
01
Overview
Phase 3, randomised, open-label trial in smoldering multiple myeloma (SMM) comparing Isatuximab + lenalidomide + dexamethasone with Lenalidomide + dexamethasone (2 arms). Primary endpoints: Treatment-emergent adverse events and serious adverse events, Plasma concentration of isatuximab during treatment and 2 more. Planned start Jun 2020; status: authorised.
02
Drugs
isatuximablenalidomidedexamethasone
03
Conditions
smoldering multiple myeloma (SMM)
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