GEM-CLARIDEX: Ld vs BiRd

Summary

This phase III study, open-label, randomized study investigating lenalidomide and dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in the USA (153)

Timeline

Start

2015-09

Primary completion

2024-10

Completion

2024-10

Publications

• Jelinek T, Bezdekova R, Zihala D, Sevcikova T, Anilkumar Sithara A, Pospisilova L, Sevcikova S, Polackova P, Stork M, Knechtova Z, Venglar O, Kapustova V, Popkova T, Muronova L, Chyra Z, Hrdinka M, Simicek M, Garces JJ, Puig N, Cedena MT, Jurczyszyn A, Castillo JJ, Penka M, Radocha J, Mateos MV, San-Miguel JF, Paiva B, Pour L, Rihova L, Hajek R. More Than 2% of Circulating Tumor Plasma Cells Defines Plasma Cell Leukemia-Like Multiple Myeloma. J Clin Oncol. 2023 Mar 1;41(7):1383-1392. doi: 10.1200/JCO.22.01226. Epub 2022 Oct 31.
• Puig N, Hernandez MT, Rosinol L, Gonzalez E, de Arriba F, Oriol A, Gonzalez-Calle V, Escalante F, de la Rubia J, Gironella M, Rios R, Garcia-Sanchez R, Arguinano JM, Alegre A, Martin J, Gutierrez NC, Calasanz MJ, Martin ML, Couto MDC, Casanova M, Arnao M, Perez-Persona E, Garzon S, Gonzalez MS, Martin-Sanchez G, Ocio EM, Coleman M, Encinas C, Vale AM, Teruel AI, Cortes-Rodriguez M, Paiva B, Cedena MT, San-Miguel JF, Lahuerta JJ, Blade J, Niesvizky R, Mateos MV. 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. doi: 10.1038/s41408-021-00490-8.

Drugs

Indications