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

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Date

2021-03-28

Authors

Puig, Noemi
Hernandez, Miguel T
Rosiñol, Laura
Gonzalez, Esther
de Arriba, Felipe
Oriol, Albert
Gonzalez-Calle, Veronica
Escalante, Fernando
de la Rubia, Javier
Gironella, Mercedes

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Nature Publishing Group
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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.

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MeSH Terms

Aged
Antineoplastic Combined Chemotherapy Protocols
Clarithromycin
Female
Hematopoietic Stem Cell Transplantation
Lenalidomide
Male
Transplantation, Autologous
Treatment Outcome

DeCS Terms

Anciano
Claritromicina
Femenino
Lenalidomida
Masculino
Protocolos de quimioterapia combinada antineoplásica
Resultado del tratamiento
Trasplante autólogo
Trasplante de células madre hematopoyéticas

CIE Terms

Keywords

Aged, 80 and over, Dexamethasone, Humans, Multiple Myeloma

Citation

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.