Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years

Summary

The study is designed as a randomized, controlled, open-label, assessor blind, multicenter superiority trial with three parallel groups, and primary endpoint of immunophenotypic complete responses at 18 months after randomization. Block randomization will be performed with a 1:1:1 allocation ratio. Patients will be randomized up front to 3 arms. Patients will receive "standard" PETHEMA arm for fit elderly VMP x 9 + Rd x 9 (arm 1, control arm), a KRd regimen (arm 2a) (18 cycles) or a Carfilzomib-lenalidomida-dexametasona regimen combined with DARATUMUMAB (arm 2b) (18 cycles).

Timeline

Start

2018-10-22

Primary completion

2023-07

Completion

2031-01

Publications

• Mateos MV, Paiva B, Cedena MT, Puig N, Sureda-Balari AM, de la Calle VG, Oriol A, Ocio EM, Rosinol L, Montes YG, Bargay J, Garcia MEG, Lakhwani S, Payer AR, Suarez-Cabrera A, Blanchard MJ, Garzon S, Montero FC, Cabanas V, de Oteyza JP, Gironella M, Martinez-Lopez J, Casasus AIT, Delgado-Beltran MP, Prieto E, Lahuerta JJ, Blade J, San-Miguel J. Induction therapy with bortezomib, melphalan, and prednisone followed by lenalidomide and dexamethasone versus carfilzomib, lenalidomide, and dexamethasone with or without daratumumab in older, fit patients with newly diagnosed multiple myeloma (GEM-2017FIT): a phase 3, open-label, multicentre, randomised clinical trial. Lancet Haematol. 2025 Aug;12(8):e588-e598. doi: 10.1016/S2352-3026(25)00143-7.

Drugs

Indications