RT Journal Article
T1 Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial.
A1 Puig, Noemi
A1 Hernandez, Miguel T
A1 Rosiñol, Laura
A1 Gonzalez, Esther
A1 de Arriba, Felipe
A1 Oriol, Albert
A1 Gonzalez-Calle, Veronica
A1 Escalante, Fernando
A1 de la Rubia, Javier
A1 Gironella, Mercedes
A1 Ríos, Rafael
A1 Garcia-Sanchez, Ricarda
A1 Arguiñano, Jose M
A1 Alegre, Adrian
A1 Martin, Jesus
A1 Gutierrez, Norma C
A1 Calasanz, Maria J
A1 Martin, Maria L
A1 Couto, Maria del Carmen
A1 Casanova, Maria
A1 Arnao, Mario
A1 Perez-Persona, Ernesto
A1 Garzon, Sebastian
A1 Gonzalez, Marta S
A1 Martin-Sanchez, Guillermo
A1 Ocio, Enrique M
A1 Coleman, Morton
A1 Encinas, Cristina
A1 Vale, Ana M
A1 Teruel, Ana I
A1 Cortes-Rodriguez, Maria
A1 Paiva, Bruno
A1 Cedena, M Teresa
A1 San-Miguel, Jesus F
A1 Lahuerta, Juan J
A1 Blade, Joan
A1 Niesvizky, Ruben
A1 Mateos, Maria-Victoria
K1 Aged, 80 and over
K1 Dexamethasone
K1 Humans
K1 Multiple Myeloma
AB 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.
PB Nature Publishing Group
YR 2021
FD 2021-03-28
LK http://hdl.handle.net/10668/17818
UL http://hdl.handle.net/10668/17818
LA en
NO 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(5):101.
DS RISalud
RD Apr 8, 2025