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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

Gregersen, Henrik ; Peceliunas, Valdas ; Remes, Kari ; Schjesvold, Fredrik ; Abildgaard, Niels ; Nahi, Hareth ; Andersen, Niels Frost ; Vangsted, Annette Juul ; Klausen, Tobias Wirenfeldt and Helleberg, Carsten , et al. (2022) In European Journal of Haematology 108(1). p.34-44
Abstract

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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
carfilzomib, induction chemotherapy, maintenance chemotherapy, multiple myeloma, salvage therapy
in
European Journal of Haematology
volume
108
issue
1
pages
34 - 44
publisher
Wiley-Blackwell
external identifiers
  • scopus:85116781048
  • pmid:34536308
ISSN
0902-4441
DOI
10.1111/ejh.13709
language
English
LU publication?
no
additional info
Publisher Copyright: © 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.
id
3698ffdc-83a1-4635-a588-b6d0701d243e
date added to LUP
2021-11-18 10:35:10
date last changed
2024-06-15 20:34:17
@article{3698ffdc-83a1-4635-a588-b6d0701d243e,
  abstract     = {{<p>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.</p>}},
  author       = {{Gregersen, Henrik and Peceliunas, Valdas and Remes, Kari and Schjesvold, Fredrik and Abildgaard, Niels and Nahi, Hareth and Andersen, Niels Frost and Vangsted, Annette Juul and Klausen, Tobias Wirenfeldt and Helleberg, Carsten and Carlson, Kristina and Frølund, Ulf Christian and Axelsson, Per and Stromberg, Olga and Blimark, Cecilie Hveding and Crafoord, Jacob and Tsykunova, Galina and Eshoj, Henrik Rode and Waage, Anders and Hansson, Markus and Gulbrandsen, Nina}},
  issn         = {{0902-4441}},
  keywords     = {{carfilzomib; induction chemotherapy; maintenance chemotherapy; multiple myeloma; salvage therapy}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{34--44}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{European Journal of Haematology}},
  title        = {{Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma : A randomised phase 2 trial by the Nordic Myeloma Study Group}},
  url          = {{http://dx.doi.org/10.1111/ejh.13709}},
  doi          = {{10.1111/ejh.13709}},
  volume       = {{108}},
  year         = {{2022}},
}