Carfilzomib Maintenance for Relapsed MM

The CARFI trial was a Nordic Myeloma Study Group open-label multi-center, randomized, phase II clinical trial, using a parallel (1:1) group design (clinicaltrials.gov: NCT02572492). Details of the study design, trial treatment and main findings have been published elsewhere [30 (link)]. In brief, patients with MM aged 18 years or more with first relapse after prior ASCT and found eligible for salvage ASCT were included at 25 hospitals within four Nordic countries and Lithuania from January 2015 to April 2018. Key exclusion criteria were previous treatment with carfilzomib, maintenance treatment given after first ASCT, World Health Organization performance status ≥ 3, significant neuropathy (grade 3–4, or grade 2 with pain) and any comorbidity that would preclude treatment with carfilzomib or salvage ASCT.
Two months after reinduction with four cycles of carfilzomib-lenalidomide-dexamethasone followed by salvage ASCT, patients were randomized to Kd maintenance or observation. Kd maintenance was given as intravenous carfilzomib (27 mg/sqm every second week with escalation of carfilzomib to 56 mg/sqm if tolerated) and oral dexamethasone 20 mg every second week until progression, unacceptable adverse effects, withdrawal of consent or 1 September 2019 (end of study). Dose modifications of carfilzomib and/or dexamethasone were done in case of toxicity related to the drugs (described in the supplementary appendix).