Longitudinal assessments of minimal residual disease in high-risk patients from benefit phase 3 randomized Study of isatuximab plus lenalidomide and dexamethasone with bortezomib (Isa-VRd) versus isard in newly diagnosed transplant ineligible multiple myeloma. (IFM 2020-05)
Year: 2025
Type: conference-abstract
Abstract: Introduction. A recent international genomic consensus staging has standardized the high-risk (HR) definition on the basis of an NGS-based definition plus serum beta-2-microglobulin level. Isa-VRd has become a standard-of-care for NDMM Transplant-Ineligible (TI). We studied the 12-24 months sustained MRD (sMRD) in high-risk patients using the genomic consensus staging in BENEFIT study. Methods. BENEFIT is a multicenter, phase 3 study, that randomized NDMM TI to receive Isa-VRd or IsaRd (ClinicalTrials.gov identifier: NCT04751877). Data are presented in intention-to-treat. IMS/IMWG new HR definition was assessed centrally by NGS on sorted plasma cells. Results. With a median follow-up of 33.4 months [95%CI, 33 - 34], 78 (29%) patients discontinued from the study, mostly for progressive disease. The HRMM (n=72, 27%) characterized 42/135 (31%) and 30/135 (22%) patients across Isa-VRd and IsaRd arms. The 18-month MRD negativity rate at 10-5, the primary end point, was similar across HRMM and non-HRMM within the same arm, and Isa-VRd remained superior for HRMM, OR 2.75 (95%CI, 1 to 7.5). Similar differences were observed at 10-6 at 18 months. The sustained MRD 12-24 months negativity rate at 10−5was higher for Isa-VRd than for IsaRd in HRMM, 31% and 13% respectively, OR 2.91 (95%CI, 0.8 to 10). There is no new safety signal observed across arms, including for HRMM. Conclusion. The results from the BENEFIT study continue to demonstrate meaningful benefit of the quadruplet-based Isa-VRd regimen in NDMM TI patients, including sMRD negativity rates. The benefits of the Isa-VRd regimen are observed in HRMM. This data supports Isa-VRd as a new SOC for NDMM TI aged of 65 to 79 patients, including for HRMM.
Source: Blood
Authors: Anais Schavgoulidze, Jerome Lambert, Arthur Bobin, Salomon Manier, Aurore Perrot, Lionel Karlin, Murielle Roussel, Noemie Bigot, Omar Benbrahim, Olivier Allangba, Philippe Rey, Veronique Dorvaux, Marguerite Vignon, Virginie Roland, Reda Garidi, Jean-Noel Bastie, Marie-Lorraine Chrétien, Sophie Godet, Lydia Montes, Cherel Brieuc, Ikhlef Souhila, Anne Vekkhof, Thomas Chalopin, Bohrane Slama, Laurent Frenzel, Emilie Chalayer, Helene Gardeney, Magaret Macro, Bruno Royer, Stephanie Harel, Olivier Decaux, Bertrand Arnulf, Karim Belhadj Merzoug, Cyrille Touzeau, Mohamad Mohty, Aurelie Gontier, Philippe Moreau, Thierry Facon, Jill Corre, Cyrille Hulin, Xavier Leleu
Institutions: Centre Hospitalier Universitaire de Toulouse, Institut universitaire du cancer de Toulouse Oncopole, Inserm, Université Paris Cité, Centre de Recherche Épidémiologie et Statistique, Université de Poitiers, Centre Hospitalier Universitaire de Poitiers, Centre Hospitalier Universitaire de Lille, Centre Hospitalier Universitaire de Limoges, Centre hospitalier universitaire d'Orléans, Centre Hospitalier de Saint-Brieuc, Centre Léon Bérard, Centre Hospitalier Régional de Metz-Thionville, Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, Centre Hospitalier de Perpignan, Centre Hospitalier de Saint-Quentin, CHU Dijon Bourgogne, Centre Hospitalier Universitaire de Reims, Centre Hospitalier Universitaire Amiens-Picardie, Centre hospitalier Bretagne Atlantique, Sorbonne Université, Hôpital Saint-Antoine, Centre Hospitalier Universitaire de Tours, Hôpital Necker-Enfants Malades, Centre Hospitalier Universitaire de Saint-Étienne, Centre Hospitalier Universitaire de Caen Normandie, Hôpital Saint-Louis, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Bordeaux
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7108439575
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