Rosiñol, LauraOriol, AlbertRios, RafaelSureda, AnnaBlanchard, María JesúsHernández, Miguel TeodoroMartínez-Martínez, RafaelMoraleda, Jose MJarque, IsidroBargay, JuanGironella, Mercedesde Arriba, FelipePalomera, LuisGonzález-Montes, YolandaMartí, Josep MKrsnik, IsabelArguiñano, Jose MGonzález, Maria EstherGonzález, Ana PilarCasado, Luis FelipeLópez-Anglada, LuciaPaiva, BrunoMateos, Maria-VictoriaSan Miguel, Jesus FLahuerta, Juan-JoséBladé, Joan2023-01-252023-01-252019http://hdl.handle.net/10668/14471Achieving 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.enAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBortezomibChemotherapy, AdjuvantDexamethasoneFemaleHematopoietic Stem Cell TransplantationHumansInduction ChemotherapyLenalidomideMaleMiddle AgedMultiple MyelomaNeoadjuvant TherapyTransplantation ConditioningTransplantation, Autologousresearch article31484647open access10.1182/blood.20190002411528-0020PMC6888142https://ashpublications.org/blood/article-pdf/134/16/1337/1248514/bloodbld2019000241.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6888142/pdf