Detalle Publicación

Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplant in multiple myeloma

Autores: Rosinol, L. ; Oriol, A. ; Rios, R. ; Sureda, A.; Blanchard, M. J. ; Hernandez, M. T.; Martinez-Martinez, R. ; Moraleda, J. M.; Jarque, I.; Bargay, J.; Gironella, M.; de Arriba, F.; Palomera, L. ; Gonzalez-Montes, Y. ; Marti, J. M. ; Krsnik, I. ; Arguinano, J. M. ; Gonzalez, M. E.; Gonzalez, A. P.; Casado, L. F.; Lopez-Anglada, L.; Paiva, Bruno; Mateos, M. V.; San Miguel Izquierdo, Jesús; Lahuerta, J. J.; Blade, J. (Autor de correspondencia)
Título de la revista: BLOOD
ISSN: 0006-4971
Volumen: 134
Número: 16
Páginas: 1337 - 1345
Fecha de publicación: 2019
Achieving and maintaining a high-quality response is the treatment goal for patients with newly diagnosed multiple myeloma (NDMM). The phase 3 PETHEMA/GEM2012 study, in 458 patients aged <= 65 years with NDMM, is evaluating bortezomib (subcutaneous) + lenalidomide + dexamethasone (VRD) for 6 cycles followed by autologous stem cell transplant (ASCT) conditioned with IV busulfan + melphalan vs melphalan and post-transplant consolidation with 2 cycles of VRD. We present grouped response analysis of induction, transplant, and consolidation. Responses deepened over time; in patients who initiated cycle 6 of induction (n = 426), the rates of a very good partial response or better were 55.6% by cycle 3, 63.8% by cycle 4, 68.3% by cycle 5, and 70.4% after induction. The complete response rate of 33.4% after induction in the intent-to-treat (ITT) population, which was similar in the 92 patients with high-risk cytogenetics (34.8%), also deepened with further treatment (44.1% after ASCT and 50.2% after consolidation). Rates of undetectable minimal residual disease (median 3 x 10(-6) sensitivity) in the ITT population also increased from induction (28.8%) to transplant (42.1%) and consolidation (45.2%). The most common grade >= 3 treatment-emergent adverse events during induction were neutropenia (12.9%) and infection (9.2%). Grade >= 2 peripheral neuropathy (grouped term) during induction was 17.0%, with a low frequency of grade 3 (3.7%) and grade 4 (0.2%) events. VRD is an effective and well-tolerated regimen for induction in NDMM with deepening response throughout induction and over the course of treatment.