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).

(1) Hospital Clínic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Spain
(2) Clinical Hematology, ICO - Hosp Germans Trias i Pujol, Spain.
(3) Hospital Universitario Virgen de las Nieves, Spain.
(4) Haematology, Institut Català d'Oncologia, Spain.
(5) Hematology, Hospital Ramon y Cajal, Spain.
(6) Hematology, Hospital Universitario de Canaria, Spain.
(7) Hospital Clínico San Carlos.
(8) Hematology., Hospital Universitario Virgen de la Arrixaca. University of Murcia, Spain.
(9) Hematology, Hospital Universitari i Politècnic La Fe, Spain.
(10) Hospital Universitario Son Llàtzer, Spain.
(11) Hospital Universitario Vall d'Hebron, Spain.
(12) Hematologia y Oncología Médica, Hospital General Universitario Morales Meseguer, Spain.
(13) Hematology, Hospital Clínico, Spain.
(14) hematologia ICO, hospital josep trueta, Spain.
(15) Hospital la Mutua de Terrassa, Spain.
(16) Hematology, Hospital Universitario Puerta de Hierro, Spain.
(17) Complejo Hospitalario de Navarra, Spain.
(18) Hematology, Hospital Cabueñes, Spain.
(19) Hospital Universitario Central de Asturias, Spain.
(20) Hematology, Hospital Virgen de la Salud, Spain.
(21) Hospital Universitario, Spain.
(22) Hematology, Clinica Universidad de Navarra, Spain.
(23) Department of Hematology, University Hospital of Salamanca/IBSAL/Cancer Research Center, Spain.
(24) Clinica Universidad de Navarra, Universidad de Navarra, Spain.
(25) Hematology, Hospital Universitario 12 de Octubre, Spain.
(26) Hospital Clínic Universitari, IDIBAPS, Barcelona, Spain.

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.

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