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Title: Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial.
Authors: Puig, Noemi
Hernández, Miguel T
Rosiñol, Laura
González, Esther
de Arriba, Felipe
Oriol, Albert
González-Calle, Verónica
Escalante, Fernando
de la Rubia, Javier
Gironella, Mercedes
Ríos, Rafael
García-Sánchez, Ricarda
Arguiñano, José M
Alegre, Adrián
Martín, Jesús
Gutiérrez, Norma C
Calasanz, María J
Martín, María L
Couto, María Del Carmen
Casanova, María
Arnao, Mario
Pérez-Persona, Ernesto
Garzón, Sebastián
González, Marta S
Martín-Sánchez, Guillermo
Ocio, Enrique M
Coleman, Morton
Encinas, Cristina
Vale, Ana M
Teruel, Ana I
Cortés-Rodríguez, María
Paiva, Bruno
Cedena, M Teresa
San-Miguel, Jesús F
Lahuerta, Juan J
Bladé, Joan
Niesvizky, Ruben
Mateos, María-Victoria
metadata.dc.subject.mesh: Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
Hematopoietic Stem Cell Transplantation
Multiple Myeloma
Transplantation, Autologous
Treatment Outcome
Issue Date: 21-May-2021
Abstract: 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 with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from This study received financial support from BMS/Celgene.
metadata.dc.identifier.doi: 10.1038/s41408-021-00490-8
Appears in Collections:Producción 2020

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