Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group
Vangsted Annette Juul; Peceliunas Valdas; Nahi Hareth; Klausen Tobias Wirenfeldt; Stromberg Olga; Helleberg Carsten; Eshoj Henrik Rode; Waage Anders; Axelsson Per; Abildgaard Niels; Crafoord Jacob; Andersen Niels Frost; Frolund Ulf Christian; Hansson Markus; Blimark Cecilie Hveding; Gregersen Henrik; Tsykunova Galina; Carlson Kristina; Schjesvold Fredrik; Gulbrandsen Nina; Remes Kari
https://urn.fi/URN:NBN:fi-fe2021120158499
Tiivistelmä
Objective: We investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma.
Methods: This randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 -> 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86).
Results: Median time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4-21.8) in the control group (HR 0.46, 95% CI 0.30-0.71; P = .0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections.
Conclusion: In summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.
Kokoelmat
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