Scientific publications
Lenalidomide and dexamethasone with or without ixazomib maintenance tailored by residual disease status in myeloma. Scientific Publication
Laura Rosiñol 1 , Albert Oriol 2 , Rafael Ríos 3 , María Jesús Blanchard 4 , Isidro Jarque 5 , Joan Bargay 6 , Miguel Teodoro Hernández 7 , Valentín Cabañas 8 , Estrella Carrillo-Cruz 9 , Anna Sureda 10 , Joaquín Martínez-López 11 , Isabel Krsnik 12 , Maria Esther González 13 , Luis Felipe Casado 14 , Josep María Martí 15 , Cristina Encinas 16 , Felipe de Arriba 17 , Luis Palomera 18 , Antonia Sampol 19 , Yolanda González-Montes 20 , Elena Cabezudo 21 , Bruno Paiva 22 , Noemí Puig 23 , María Teresa Cedena 24 , Javier de la Cruz 25 , María-Victoria Mateos 23 , Jesús San Miguel 22 , Juan José Lahuerta 11 , Joan Bladé 1
Abstract
From November 2014 to May 2017, 332 patients homogeneously treated with bortezomib, lenalidomide, and dexamethasone (VRD) induction, autologous stem cell transplant, and VRD consolidation were randomly assigned to receive maintenance therapy with lenalidomide and dexamethasone (RD; 161 patients) vs RD plus ixazomib (IRD; 171 patients).
RD consisted of lenalidomide 15 mg/d from days 1 to 21 plus dexamethasone 20 mg/d on days 1 to 4 and 9 to 12 at 4-week intervals, whereas in the IRD arm, oral ixazomib at a dose of 4 mg on days 1, 8, and 15 was added. Therapy for patients with negative measurable residual disease (MRD) after 24 cycles was discontinued, whereas those who tested positive for MRD remained on maintenance with RD for 36 more cycles.
After a median follow-up of 69 months from the initiation of maintenance, the progression-free survival (PFS) was similar in both arms, with a 6-year PFS rate of 61.3% and 55.6% for RD and IRD, respectively (hazard ratio, 1.136; 95% confidence interval, 0.809-1.603). After 2 years of maintenance, treatment was discontinued in 163 patients with negative MRD, whereas 63 patients with positive MRD continued with RD therapy. Maintenance discontinuation in patients tested negative for MRD resulted in a low progression rate (17.2% at 4 years), even in patients with high-risk features.
In summary, our results show the efficacy of RD maintenance and support the safety of maintenance therapy discontinuation in patients with negative MRD at 2 years. This trial was registered at www.clinicaltrials.gov as #NCT02406144 and at EudraCT as 2014-00055410.
CITATION Blood. 2023 Nov 2;142(18):1518-1528. doi: 10.1182/blood.2022019531
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