This phase 3 study randomized 270 transplant-ineligible multiple myeloma patients (aged 65–79) to isatuximab plus lenalidomide and dexamethasone (IsaRd) or the same regimen plus weekly bortezomib (Isa-VRd). The primary endpoint was 18-month minimal residual disease (MRD) negativity rate at 10⁻⁵. Isa-VRd showed significantly higher MRD negativity rates (53% vs 26%) and complete response rates (58% vs 33%) than IsaRd. At a median follow-up of 23.5 months, survival differences were not observed. Isa-VRd is proposed as a new standard of care.

Xavier Leleu, Cyrille Hulin, Jerome Lambert, Arthur Bobin, Aurore Perrot, Lionel Karlin, Murielle Roussel, Lydia Montes, Brieuc Cherel, Thomas Chalopin, Borhane Slama, Marie-Lorraine Chretien, Kamel Laribi, Claire Dingremont, Christophe Roul, Clara Mariette, Sophie Rigaudeau, Claire Calmettes, Mamoun Dib, Mourad Tiab, Laure Vincent, Jacques Delaunay, Alberto Santagostino, Margaret Macro, Emmanuelle Bourgeois, Frederique Orsini-Piocelle, Julie Gay, Benoit Bareau, Noemie Bigot, François Vergez, Pierre Lebreton, Reza Tabrizi, Agathe Waultier-Rascalou, Laurent Frenzel, Ronan Le Calloch, Emilie Chalayer, Thorsten Braun, Florence Lachenal, Selim Corm, Celine Kennel, Rakiba Belkhir, Jean-Sebastien Bladé, Bertrand Joly, Valentine Richez-Oliver, Helene Gardeney, Helene Demarquette, Daniela Robu-Cretu, Laurent Garderet, Muriel Newinger-Porte, Amine Kasmi, Bruno Royer, Olivier Decaux, Bertrand Arnulf, Karim Belhadj, Cyrille Touzeau, Mohamad Mohty, Salomon Manier, Philippe Moreau, Hervé Avet-Loiseau, Jill Corre, Thierry Facon