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

Publikation: Bidrag til tidsskriftTidsskriftartikelpeer review

DOI

  • 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 Hansson
  • Nina Gulbrandsen
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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
Antal sider11
ISSN0902-4441
DOI
StatusUdgivet - jan. 2022

Bibliografisk note

© 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.

ID: 79442037