TY - JOUR
T1 - Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma
T2 - A randomised phase 2 trial by the Nordic Myeloma Study Group
AU - Gregersen, Henrik
AU - Peceliunas, Valdas
AU - Remes, Kari
AU - Schjesvold, Fredrik
AU - Abildgaard, Niels
AU - Nahi, Hareth
AU - Andersen, Niels Frost
AU - Vangsted, Annette Juul
AU - Klausen, Tobias Wirenfeldt
AU - Helleberg, Carsten
AU - Carlson, Kristina
AU - Frølund, Ulf Christian
AU - Axelsson, Per
AU - Stromberg, Olga
AU - Blimark, Cecilie Hveding
AU - Crafoord, Jacob
AU - Tsykunova, Galina
AU - Eshoj, Henrik Rode
AU - Waage, Anders
AU - Hansson, Markus
AU - Gulbrandsen, Nina
N1 - © 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - carfilzomib
KW - induction chemotherapy
KW - maintenance chemotherapy
KW - multiple myeloma
KW - salvage therapy
UR - http://www.scopus.com/inward/record.url?scp=85116781048&partnerID=8YFLogxK
U2 - 10.1111/ejh.13709
DO - 10.1111/ejh.13709
M3 - Journal article
C2 - 34536308
SN - 0902-4441
VL - 108
SP - 34
EP - 44
JO - European Journal of Haematology
JF - European Journal of Haematology
IS - 1
ER -