دورية أكاديمية
Randomized phase II study of weekly carfilzomib 70 mg/m(2) and dexamethasone with or without cyclophosphamide in relapsed and/or refractory multiple myeloma patients
| العنوان: | Randomized phase II study of weekly carfilzomib 70 mg/m(2) and dexamethasone with or without cyclophosphamide in relapsed and/or refractory multiple myeloma patients |
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| المؤلفون: | Pueras, Borja, González-Calle, Verónica, Sureda, Anna, Moreno, María José, Oriol, Albert, González, Esther, Rosiñol, Laura, López, Jordi, Escalante, Fernando, Martínez-López, Joaquín, Carrillo, Estrella, Clavero, Esther, Ríos-Tamayo, Rafael, Rey-Bua, Beatriz, González-Rodríguez, Ana Pilar, Dourdil, Victoria, Arriba, Felipe de, González, Sonia, Ocio San Miguel, Enrique María |
| المساهمون: | Universidad de Cantabria |
| المصدر: | Haematologica, 2023, 108(10), 2753-2763 |
| بيانات النشر: | Ferrata Storti Foundation |
| سنة النشر: | 2023 |
| المجموعة: | Universidad de Cantabria: UCrea |
| الوصف: | 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. ; Acknowledgments: The authors would like to thank to Roberto Maldonado for his help with data management and Philip Mason for language revision of the manuscript. Funding: The PETHEMA Foundation ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0390-6078 1592-8721 |
| العلاقة: | https://hdl.handle.net/10902/31012Test |
| DOI: | 10.3324/haematol.2022.282490 |
| الإتاحة: | https://doi.org/10.3324/haematol.2022.282490Test https://hdl.handle.net/10902/31012Test |
| حقوق: | Attribution-NonCommercial 4.0 International ; ©2023 Ferrata Storti Foundation ; http://creativecommons.org/licenses/by-nc/4.0Test/ ; openAccess |
| رقم الانضمام: | edsbas.1E3599B9 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 03906078 15928721 |
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| DOI: | 10.3324/haematol.2022.282490 |