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DC Field | Value | Language |
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dc.contributor.author | Puertas, Borja | - |
dc.contributor.author | González Calle, Verónica | - |
dc.contributor.author | Sureda, Anna | - |
dc.contributor.author | Moreno, María José | - |
dc.contributor.author | Oriol, Albert | - |
dc.contributor.author | González, Esther | - |
dc.contributor.author | Rosiñol, Laura | - |
dc.contributor.author | López, Jordi | - |
dc.contributor.author | Escalante, Fernando | - |
dc.contributor.author | Martínez Lopez, Joaquín | - |
dc.contributor.author | Carrillo, Estrella | - |
dc.contributor.author | Clavero, Esther | - |
dc.contributor.author | Ríos Tamayo, Rafael | - |
dc.contributor.author | Rey Bua, Beatriz | - |
dc.contributor.author | González Rodríguez, Ana Pilar | - |
dc.contributor.author | Dourdil, Victoria | - |
dc.contributor.author | Arriba, Felipe de | - |
dc.contributor.author | González, Sonia | - |
dc.contributor.author | Pérez de Oteyza, Jaime | - |
dc.contributor.author | Hernández, Miguel T. | - |
dc.contributor.author | García Mateo, Aránzazu | - |
dc.contributor.author | Bargay, Joan | - |
dc.contributor.author | Bladé, Joan | - |
dc.contributor.author | Lahuerta, Juan José | - |
dc.contributor.author | San Miguel, Jesús F. | - |
dc.contributor.author | Ocio, Enrique M. | - |
dc.contributor.author | Mateos, María Victoria | - |
dc.date.accessioned | 2024-02-16T16:24:12Z | - |
dc.date.available | 2024-02-16T16:24:12Z | - |
dc.date.issued | 2023-04-27 | - |
dc.identifier.issn | 1592-8721 | - |
dc.identifier.uri | http://hdl.handle.net/2445/207683 | - |
dc.description.abstract | 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. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Ferrata Storti Foundation (Haematologica) | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3324/haematol.2022.282490 | - |
dc.relation.ispartof | Haematologica, 2023, vol. 108, num. 10, p. 2753-2763 | - |
dc.relation.uri | https://doi.org/10.3324/haematol.2022.282490 | - |
dc.rights | cc by (c) Puertas, Borja et al., 2023 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Ciclofosfamida | - |
dc.subject.classification | Mieloma múltiple | - |
dc.subject.other | Cyclophosphamide | - |
dc.subject.other | Multiple myeloma | - |
dc.title | Randomized phase II study of weekly carfilzomib 70 mg/m<sup>2</sup> and dexamethasone with or without cyclophosphamide in relapsed and/or refractory multiple myeloma patients | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2024-02-16T13:25:53Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 37102598 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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11068-Article Text-81022-2-10-20230926.pdf | 986.07 kB | Adobe PDF | View/Open |
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