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Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial

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 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.

Otras publicaciones de la misma revista o congreso con autores/as de la Universidad de Cantabria

 Fuente: Blood Cancer J . 2021 May 21;11(5):101

Editorial: Nature Pub. Group

 Año de publicación: 2021

Nº de páginas: 11

Tipo de publicación: Artículo de Revista

 DOI: 10.1038/s41408-021-00490-8

ISSN: 2044-5385

Url de la publicación: https://doi.org/10.1038/s41408-021-00490-8

Autores/as

PUIG, NOEMI

HERNÁNDEZ, MIGUEL T.

ROSIÑOL, LAURA

GONZÁLEZ, ESTHER

ARRIBA, FELIPE DE

ORIOL, ALBERT

GONZÁLEZ-CALLE, VERÓNICA

ESCALANTE, FERNANDO

RUBIA, JAVIER DE LA

GIRONELLA, MERCEDES

RÍOS, RAFAEL

GARCÍA-SÁNCHEZ, RICARDA

ARGUIÑANO, JOSÉ M.

ALEGRE, ADRIÁN

MARTÍN, JESÚS

GUTIÉRREZ, NORMA. C. GUTIÉRREZ

CALASANZ, MARÍA J.

MARTÍN, MARÍA L.

COUTO, MARÍA DEL CARMEN