Trial intelligence / Profile preview

GEM21menos65 in transplant-eligible newly diagnosed multiple myeloma

2024-517008-12-00Phase 3Authorised

Sponsor
PETHEMA
Start
Oct 2024
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Reversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
1
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Overview

Phase 3, randomised, open-label trial of isatuximab, iberdomide, bortezomib, lenalidomide and dexamethasone in multiple myeloma (MM) (3 arms), sponsored by PETHEMA. Primary endpoints: MRD negativity improvement for Arm A versus Arm B using B1 definition and MRD negativity non-inferiority for Arm A versus Arm B using B2 definition. Planned start Oct 2024; status: authorised.

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Drugs

isatuximabiberdomidebortezomiblenalidomidedexamethasone
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Conditions

multiple myeloma (MM)

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