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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 (author)
Aalborg Univ Hosp, Dept Haematol, Molleparkvej 4, DK-9000 Aalborg, Denmark.
Peceliunas, Valdas (author)
Vilnius Univ, Hosp Santaros Klin, Dept Haematol, Vilnius, Lithuania.
Remes, Kari (author)
Turku Univ Hosp, Dept Haematol, Turku, Finland.
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Schjesvold, Fredrik (author)
Oslo Univ Hosp, Oslo Myeloma Ctr, Oslo, Norway.;Univ Oslo, KG Jebsen Ctr B Cell Malignancies, Oslo, Norway.
Abildgaard, Niels (author)
Odense Univ Hosp, Dept Haematol, Odense, Denmark.;Univ Southern Denmark, Dept Clin Res, Odense, Denmark.
Nahi, Hareth (author)
Karolinska Institutet
Andersen, Niels Frost (author)
Aarhus Univ Hosp, Dept Haematol, Aarhus, Denmark.
Vangsted, Annette Juul (author)
Rigshosp, Dept Haematol, Copenhagen, Denmark.
Klausen, Tobias Wirenfeldt (author)
Herlev Hosp, Dept Haematol, Herlev, Denmark.
Helleberg, Carsten (author)
Herlev Hosp, Dept Haematol, Herlev, Denmark.
Carlson, Kristina (author)
Uppsala universitet,Hematologi
Frolund, Ulf Christian (author)
Zealand Univ Hosp, Dept Haematol, Roskilde, Denmark.
Axelsson, Per (author)
Helsingborg Hosp, Dept Haematol, Helsingborg, Sweden.
Stromberg, Olga (author)
Karolinska Univ Hosp, Dept Haematol, Stockholm, Sweden.
Blimark, Cecilie Hveding (author)
Sahlgrens Univ Hosp, Dept Haematol, Gothenburg, Sweden.
Crafoord, Jacob (author)
Örebro Univ Hosp, Dept Haematol, Örebro, Sweden.
Tsykunova, Galina (author)
Haukeland Hosp, Dept Haematol, Bergen, Norway.
Eshoj, Henrik Rode (author)
Odense Univ Hosp, Qual Life Res Ctr, Dept Haematol, Odense, Denmark.;Odense Univ Hosp, Open Patient Data Explorat Network, OPEN, Odense, Denmark.
Waage, Anders (author)
Norwegian Univ Sci & Technol, St Olavs Hosp, Dept Haematol, Trondheim, Norway.;Norwegian Univ Sci & Technol, Inst Clin & Mol Med, Trondheim, Norway.
Hansson, Markus (author)
Skane Univ Hosp, Dept Haematol, Lund, Sweden.
Gulbrandsen, Nina (author)
Oslo Univ Hosp, Oslo Myeloma Ctr, Oslo, Norway.
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Aalborg Univ Hosp, Dept Haematol, Molleparkvej 4, DK-9000 Aalborg, Denmark Vilnius Univ, Hosp Santaros Klin, Dept Haematol, Vilnius, Lithuania. (creator_code:org_t)
2021-10-11
2022
English.
In: European Journal of Haematology. - : John Wiley & Sons. - 0902-4441 .- 1600-0609. ; 108:1, s. 34-44
  • Journal article (peer-reviewed)
Abstract Subject headings
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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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Hematologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Hematology (hsv//eng)

Keyword

carfilzomib
induction chemotherapy
maintenance chemotherapy
multiple myeloma
salvage therapy

Publication and Content Type

ref (subject category)
art (subject category)

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