• Laura Rosiñol, Albert Oriol, Rafael Rios, Anna Sureda, María Jesús Blanchard, Miguel Teodoro Hernández, Rafael Martínez-Martínez, Jose M Moraleda, Isidro Jarque, Juan Bargay, Mercedes Gironella, Felipe de Arriba, Luis Palomera, Yolanda González-Montes, Josep M Martí, Isabel Krsnik, Jose M Arguiñano, Maria Esther González, Ana Pilar González, Luis Felipe Casado, Lucia López-Anglada, Bruno Paiva, Maria-Victoria Mateos, San MiguelJesus FJFClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain; and., Juan-José Lahuerta, and Joan Bladé.
• Hospital Clínic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
• Blood. 2019 Oct 17; 134 (16): 1337-1345.

AbstractAchieving 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 posttransplant 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 × 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. This trial was registered at www.clinicaltrials.gov as #NCT01916252 and EudraCT as #2012-005683-10.© 2019 by The American Society of Hematology.

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