title: Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial.
abstract: 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 ≥ 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.
authors.affiliation: Department of Medicine, Section of Hematology and Coagulation, Sahlgrenska University Hospital, Gothenburg, Sweden. ulf-henrik.mellqvist@vgregion.se
authors.forename: Ulf-Henrik
authors.initials: UH
authors.lastname: Mellqvist
authors.forename: Peter
authors.initials: P
authors.lastname: Gimsing
authors.forename: Oyvind
authors.initials: O
authors.lastname: Hjertner
authors.forename: Stig
authors.initials: S
authors.lastname: Lenhoff
authors.forename: Edward
authors.initials: E
authors.lastname: Laane
authors.forename: Kari
authors.initials: K
authors.lastname: Remes
authors.forename: Hlif
authors.initials: H
authors.lastname: Steingrimsdottir
authors.forename: Niels
authors.initials: N
authors.lastname: Abildgaard
authors.forename: Lucia
authors.initials: L
authors.lastname: Ahlberg
authors.forename: Cecilie
authors.initials: C
authors.lastname: Blimark
authors.forename: Inger Marie
authors.initials: IM
authors.lastname: Dahl
authors.forename: Karin
authors.initials: K
authors.lastname: Forsberg
authors.forename: Tobias
authors.initials: T
authors.lastname: Gedde-Dahl
authors.forename: Henrik
authors.initials: H
authors.lastname: Gregersen
authors.forename: Astrid
authors.initials: A
authors.lastname: Gruber
authors.forename: Nina
authors.initials: N
authors.lastname: Guldbrandsen
authors.forename: Einar
authors.initials: E
authors.lastname: Haukås
authors.forename: Kristina
authors.initials: K
authors.lastname: Carlson
authors.forename: Ann Kristin
authors.initials: AK
authors.lastname: Kvam
authors.forename: Hareth
authors.initials: H
authors.lastname: Nahi
authors.forename: Roald
authors.initials: R
authors.lastname: Lindås
authors.forename: Niels Frost
authors.initials: NF
authors.lastname: Andersen
authors.forename: Ingemar
authors.initials: I
authors.lastname: Turesson
authors.forename: Anders
authors.initials: A
authors.lastname: Waage
authors.forename: Jan
authors.initials: J
authors.lastname: Westin
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D011379:Prognosis; D011719:Pyrazines / Q000627:therapeutic use*; D011788:Quality of Life; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014182:Transplantation, Autologous
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib