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Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial

Mellqvist, Ulf-Henrik (author)
Sahlgrens University Hospital, Sweden
Gimsing, Peter (author)
Rigshosp, Denmark
Hjertner, Oyvind (author)
Norwegian University of Science and Technology, Norway
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Lenhoff, Stig (author)
Lund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Skåne University Hospital, Sweden
Laane, Edward (author)
North Estonian Regional Hospital, Estonia
Remes, Kari (author)
Turku University, Finland
Steingrimsdottir, Hlif (author)
Landspitali University Hospital, Iceland
Abildgaard, Niels (author)
Odense University Hospital, Denmark
Ahlberg, Lucia (author)
Östergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Hematologiska kliniken US
Blimark, Cecilie (author)
Sahlgrens University Hospital, Sweden
Dahl, Inger Marie (author)
University of North Norway, Norway
Forsberg, Karin (author)
Umeå universitet,Patologi,Norrlands University Hospital, Sweden
Gedde-Dahl, Tobias (author)
Oslo University Hospital, Norway
Gregersen, Henrik (author)
Aalborg Hospital, Denmark
Gruber, Astrid (author)
Karolinska Institute, Sweden
Guldbrandsen, Nina (author)
Oslo University Hospital, Norway
Haukas, Einar (author)
Stavanger University Hospital, Norway
Carlson, Kristina (author)
Uppsala universitet,Hematologi,Akad University Hospital, Sweden
Kvam, Ann Kristin (author)
Oslo University Hospital, Norway
Nahi, Hareth (author)
Karolinska Institutet,Karolinska Institute, Sweden
Lindas, Roald (author)
Haukeland Hospital, Norway
Frost Andersen, Niels (author)
Aarhus University Hospital, Denmark
Turesson, Ingemar (author)
Lund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Skåne University Hospital, Sweden
Waage, Anders (author)
Norwegian University of Science and Technology, Norway
Westin, Jan (author)
Sahlgrens University Hospital, Sweden
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 (creator_code:org_t)
American Society of Hematology, 2013
2013
English.
In: Blood. - : American Society of Hematology. - 0006-4971 .- 1528-0020. ; 121:23, s. 4647-4654
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the andgt;= VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911.

Subject headings

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

Keyword

MEDICINE
MEDICIN

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