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Título: | Randomized phase II study of weekly carfilzomib 70 mg/m2 and dexamethasone with or without cyclophosphamide in relapsed and/or refractory multiple myeloma patients |
Autor: | Puertas Martínez, Borja; González-Calle, Verónica; Sureda, Anna; Moreno, María José; Oriol, Albert; González, Esther; Rosiñol, Laura; López, Jordi; Escalante, Fernando; Martínez-López, Joaquín; Carrillo Cruz, Estrella; Clavero, Esther; Ríos-Tamayo, R.; Rey-Bua, Beatriz; Gonzalez-Rodriguez, Ana Pilar; Dourdil, Mª Victoria; Arriba, Felipe de; González, Sonia; Pérez de Oteyza, Jaime; Hernandez, Miguel T.; García-Mateo, Aránzazu; Bargay, Joan; Bladé, Joan; Lahuerta, Juan José; San Miguel, Jesús F. CSIC ORCID; Ocio, Enrique M. CSIC ORCID ; Mateos, Maria Victoria | Fecha de publicación: | oct-2023 | Editor: | Ferrata Storti Foundation | Citación: | Haematologica 108(10): 2753-2763 (2023) | Resumen: | In this randomized phase II study (GEM-KyCyDex, clinicaltrials gov. Identifier: NCT03336073), the combination of weekly carfilzomib 70 mg/m2, cyclophosphamide and dexamethasone (KCd) was compared to carfilzomib and dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM) after 1-3 prior lines (PL). One hundred and ninety-seven patients were included and randomized 1:1 to receive KCd (97 patients) or Kd (100 patients) in 28-day cycles until progressive disease or unacceptable toxicity occurred. Patient median age was 70 years, and the median number of PL was one (range, 1-3). More than 90% of patients had previously been exposed to proteasome inhibitors, approximetely 70% to immunomodulators, and approximetely 50% were refractory to their last line (mainly lenalidomide) in both groups. After a median follow-up of 37 months, median progression-free survival (PFS) was 19.1 and 16.6 months in KCd and Kd, respectively (P=0.577). Of note, in the post hoc analysis of the lenalidomide-refractory population, the addition of cyclophosphamide to Kd resulted in a significant benefit in terms of PFS: 18.4 versus 11.3 months (hazard ratio =1.7, 95% confidence interval: 1.1-2.7; P=0.043). The overall response rate and the percentage of patients who achieved complete response was around 70% and 20% in both groups. The addition of cyclophosphamide to Kd did not result in any safety signal, except for severe infections (7% vs. 2%). In conclusion, the combination of cyclophosphamide with Kd 70 mg/m2 weekly does not improve outcomes as compared with Kd alone in RRMM after 1-3 PL, but a significant benefit in PFS was observed with the triplet combination in the lenalidomide-refractory population. The administration of weekly carfilzomib 70 mg/m2 was safe and convenient, and, overall, the toxicity was manageable in both arms. | Versión del editor: | https://doi.org/10.3324/haematol.2022.282490 | URI: | http://hdl.handle.net/10261/352546 | DOI: | 10.3324/haematol.2022.282490 | ISSN: | 0390-6078 | E-ISSN: | 1592-8721 |
Aparece en las colecciones: | (IBMCC) Artículos (IBIS) Artículos |
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