Scientific publications

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

Sep 4, 2019 | Magazine: Blood

Rosiñol L (1), Oriol A (2), Rios R (3), Sureda A (4), Blanchard MJ (5), Hernández MT (6), Martínez-Martínez R (7), Moraleda JM (8), Jarque I (9), Bargay J (10), Gironella M (11), de Arriba F (12), Palomera L (13), Gonzalez-Montes Y (14), Marti J (15), Krsnik I (16), Arguiñano JM (17), Gonzalez ME (18), Gonzalez AP (19), Casado LF (20), Lopez-Anglada L (21), Paiva B (22), Mateos MV (23), San Miguel J (24), Lahuerta JJ (25), Bladé J (26).

Achieving and maintaining high-quality response is the treatment goal for patients with newly diagnosed multiple myeloma (NDMM).

The phase 3 PETHEMA/GEM2012 study, in 458 patients {less than or equal to} 65 years old with NDMM, is evaluating bortezomib (subcutaneous) + lenalidomide + dexamethasone (VRD) for 6 cycles followed by autologous stem cell transplant (ASCT) conditioned with intravenous 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 {greater than or equal to} very good partial response rates 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 {greater than or equal to} 3 treatment-emergent adverse events during induction were neutropenia (12.9%) and infection (9.2%). Grade {greater than or equal to} 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 (NCT01916252) and EudraCT (2012-005683-10).

CITATION  Blood. 2019 Sep 4. pii: blood.2019000241. doi: 10.1182/blood.2019000241.