GEM2017Fit Phase 3 Trial in Fit Elderly Patients (Aged 65-80) with Newly Diagnosed Myeloma: Impact of Daratumumab at Induction and/or Consolidation

• Published in: Blood 2024-11, Vol.144 (Supplement 1), p.678-678
• Main Authors: Mateos, Maria- Victoria, Paiva, Bruno, Cedena Romero, Maria Teresa, Puig, Noemi, Sureda Balari, Anna, Oriol, Albert, Ocio, Enrique M, Rosiñol, Laura, González-Montes, Yolanda, Bargay, Joan, Gonzalez Garcia, Esther, Hernández Garcia, Miguel Teodoro, Ramirez, Angel, Suarez-Cabrera, Alexia, Blanchard, María-Jesús, Garzón, Sebastián, Casado, Luis Felipe, Cabanas Perianes, Valentin, Perez de Oteyza, Jaime, Gironella, Mercedes, Martínez-López, Joaquin, -Teruel, Ana-Isabel, Delgado, Pilar, Prieto, Elena, Lahuerta Palacios, Juan-Jose, Bladé, Joan, San-Miguel, Jesús F.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2024-203170

Background: In patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for transplant, VMP (bortezomib, melphalan, prednisone) and Rd (lenalidomide, dexamethasone) have been standard treatments. The Spanish Myeloma Group combined 9 cycles of VMP and 9 cycles of Rd, yielding good results for “fit” patients aged 65-80. They achieved a complete response (CR) rate of 47%, with 20% of patients being minimal residual disease negative (MRD-ve). The median progression-free survival (PFS) was 34 months, and the 4-year overall survival (OS) was 70%. Patients and Study Design: Building on these results, we conducted a study comparing VMP9-Rd9 (control arm) with KRd (carfilzomib, lenalidomide, dexamethasone) and D-KRd (daratumumab, carfilzomib, lenalidomide, dexamethasone). The induction phase included 18 cycles, with the primary endpoint being the MRD-ve rate after induction. This primary endpoint was met, with significantly higher MRD-ve rates observed in both the KRd group [53.9%, Odds Ratio (OR) = 1.74, 95% CI: 1.39-2.16, p