Lenalidomide and dexamethasone maintenance with or without ixazomib, tailored by residual disease status in myeloma

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...

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Detalles Bibliográficos
Autores: Rosiñol Dachs, Laura, Oriol, Albert, Rios, Rafael, Blanchard, Maria Jesús, Jarque, Isidro, Bargay, Joan, Hernández, Miguel Teodoro, Cabanas, Valentín, Carrillo Cruz, Estrella, Sureda, Anna, Martínez López, Joaquín, Krsnik, Isabel, González, María Esther, Casado, Luís Felipe, Martí, Josep Maria, Encinas, Cristina, Arriba, Felipe de, Palomera, Luis, Sampol, Antonia, Gonzalez Montes, Yolanda, Cabezudo, Elena, Paiva, Bruno, Puig, Noemí, Cedena, Maria Teresa, Cruz, Javier de la, Mateos, María Victoria, San Miguel, Jesús, Lahuerta, Juan José, Bladé, J. (Joan)
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/207533
Acceso en línea:https://hdl.handle.net/2445/207533
Access Level:acceso abierto
Palabra clave:Mieloma múltiple
Quimioteràpia
Multiple myeloma
Chemotherapy
Descripción
Sumario: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.

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