Publicaciones científicas

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

21-may-2021 | Revista: Blood Cancer Journal

Noemi Puig  1 , Miguel T Hernández  2 , Laura Rosiñol  3 , Esther González  4 , Felipe de Arriba  5 , Albert Oriol  6 , Verónica González-Calle  1 , Fernando Escalante  7 , Javier de la Rubia  8 , Mercedes Gironella  9 , Rafael Ríos  10 , Ricarda García-Sánchez  11 , José M Arguiñano  12 , Adrián Alegre  13 , Jesús Martín  14 , Norma C Gutiérrez  1 , María J Calasanz  15 , María L Martín  16 , María Del Carmen Couto  17 , María Casanova  18 , Mario Arnao  19 , Ernesto Pérez-Persona  20 , Sebastián Garzón  21 , Marta S González  22 , Guillermo Martín-Sánchez  23 , Enrique M Ocio  1 , Morton Coleman  24 , Cristina Encinas  25 , Ana M Vale  26 , Ana I Teruel  27 , María Cortés-Rodríguez  1   28 , Bruno Paiva  15 , M Teresa Cedena  16 , Jesús F San-Miguel  15 , Juan J Lahuerta  29 , Joan Bladé  3 , Ruben Niesvizky  24 , María-Victoria Mateos  30


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.

CITA DEL ARTÍCULO  Blood Cancer J. 2021 May 21;11(5):101.  doi: 10.1038/s41408-021-00490-8

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