Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group

Henrik Gregersen*, Valdas Peceliunas, Kari Remes, Fredrik Schjesvold, Niels Abildgaard, Hareth Nahi, Niels Frost Andersen, Annette Juul Vangsted, Tobias Wirenfeldt Klausen, Carsten Helleberg, Kristina Carlson, Ulf Christian Frølund, Per Axelsson, Olga Stromberg, Cecilie Hveding Blimark, Jacob Crafoord, Galina Tsykunova, Henrik Rode Eshoj, Anders Waage, Markus HanssonNina Gulbrandsen

*Kontaktforfatter for dette arbejde

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Abstrakt

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.

OriginalsprogEngelsk
TidsskriftEuropean journal of haematology
Vol/bind108
Udgave nummer1
Sider (fra-til)34-44
ISSN0902-4441
DOI
StatusUdgivet - jan. 2022

Bibliografisk note

Funding Information:
The study received financial support and free study drug from Amgen. The authors would like to thank Peter Gimsing for inspiration for the study, Sanne Kjær at the Clinical Trial Unit, Aalborg University Hospital for administrative assistance, www.FACIT.org for permission to use the FACT/GOG‐NTX Scale, EORTC for permission to use the quality of life QLQ‐C30 and MY20 questionnaires, Open Patient data Explorative Network (OPEN) for help with the QOL data and Berit Bjelkåsen, Enhet for anvendt klinisk forskning (AKF) at NTNU in Trondheim, Norway for data management. Finally, we thank the patients and staff members at the trial sites for participation in the trial.

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