دورية أكاديمية
Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial
| العنوان: | Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial |
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| المؤلفون: | Puig, Noemi, Hernández, Miguel T., González, Esther, de Arriba, Felipe, Gironella Mesa, Mercedes, Rosiñol, Laura, Oriol, Albert |
| المساهمون: | Institut Català de la Salut, Puig N Hematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain. Hernández MT Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. Rosiñol L Hematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain. González E Hospital Universitario de Cabueñes, Gijón, Spain. de Arriba F Hospital Morales Meseguer, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain. Oriol A Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain. Gironella M Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Scientia |
| بيانات النشر: | Springer Nature |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Mieloma múltiple - Tractament, Teràpia cel·lular, DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma, Other subheadings::Other subheadings::Other subheadings::/drug therapy, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Transplantation::Transplantation, Autologous, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Therapy, Combination, ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células plasmáticas::mieloma múltiple, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::trasplante::trasplante autólogo, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::farmacoterapia combinada |
| الوصف: | Mieloma; Assajos controlats aleatoris ; Mieloma; Ensayos controlados aleatorios ; Myeloma; Randomized controlled trials ; Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0–54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3–4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the ≥CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2044-5385 |
| العلاقة: | Blood Cancer Journal;11; https://doi.org/10.1038/s41408-021-00490-8Test; Puig N, Hernández MT, Rosiñol L, González E, de Arriba F, Oriol A, et al. Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial. Blood Cancer J. 2021 May 21;11:101.; https://hdl.handle.net/11351/6807Test; 000657750600003 |
| DOI: | 10.1038/s41408-021-00490-8 |
| الإتاحة: | https://doi.org/10.1038/s41408-021-00490-8Test https://hdl.handle.net/11351/6807Test |
| حقوق: | Attribution 4.0 International ; http://creativecommons.org/licenses/by/4.0Test/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.DA1020AB |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20445385 |
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| DOI: | 10.1038/s41408-021-00490-8 |