RT Journal Article
T1 Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplant in multiple myeloma.
A1 Rosiñol, Laura
A1 Oriol, Albert
A1 Rios, Rafael
A1 Sureda, Anna
A1 Blanchard, María Jesús
A1 Hernández, Miguel Teodoro
A1 Martínez-Martínez, Rafael
A1 Moraleda, Jose M
A1 Jarque, Isidro
A1 Bargay, Juan
A1 Gironella, Mercedes
A1 de Arriba, Felipe
A1 Palomera, Luis
A1 González-Montes, Yolanda
A1 Martí, Josep M
A1 Krsnik, Isabel
A1 Arguiñano, Jose M
A1 González, Maria Esther
A1 González, Ana Pilar
A1 Casado, Luis Felipe
A1 López-Anglada, Lucia
A1 Paiva, Bruno
A1 Mateos, Maria-Victoria
A1 San Miguel, Jesus F
A1 Lahuerta, Juan-José
A1 Bladé, Joan
AB 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 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.
YR 2019
FD 2019
LK http://hdl.handle.net/10668/14471
UL http://hdl.handle.net/10668/14471
LA en
DS RISalud
RD Apr 7, 2025