title: Salvage bortezomib-dexamethasone and high-dose melphalan (HDM) and autologous stem cell support (ASCT) in myeloma patients at first relapse after HDM with ASCT. A phase-2 trial.
abstract: Until recently, only retrospective studies had been published on salvage high-dose melphalan (HDM) with autologous stem cell 'transplantation' (ASCT). In a prospective, nonrandomized phase-2 study, we treated 53 bortezomib-naïve patients with bortezomib-dexamethasone as induction and bortezomib included in the conditioning regimen along with the HDM. Median progression-free survival (PFS), time to next treatment (TNT) and overall survival (OS) after start of reinduction therapy were 21.6, 22.8 and 46.6 months, respectively. For 49 patients who completed salvage bortezomib-HDM(II) with ASCT, there was no significant difference of PFS and TNT after HDM (II) compared with after the initial HDM(I), and thus patients were their own controls (PFS (I: 20.1 vs II: 19.3 months (P=0.8)) or TNT (I: 24.4 vs II: 20.7 months (P=0.8)). No significant differences in the response rates after salvage ASCT compared with the initial ASCT. Bortezomib-HDM conditioning combo was feasible, and toxicity was as expected for patients treated with bortezomib and ASCT. In conclusion, in bortezomib-naïve patients treated at first relapse with salvage ASCT including bortezomib, PSF and TNT did not differ significantly from initial ASCT and median OS was almost 5.5 years with acceptable toxicity. A recent prospective randomized study confirms salvage ASCT to be an effective treatment.
authors.affiliation: Department of Hematology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Gimsing
authors.affiliation: Department of Hematology, St. Olavs University Hospital, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
authors.forename: Ø
authors.initials: Ø
authors.lastname: Hjertner
authors.affiliation: Department of Hematology, Odense University Hospital, University of Southern Denmark, Odense, Denmark.
authors.forename: N
authors.initials: N
authors.lastname: Abildgaard
authors.affiliation: Department of Hematology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: N F
authors.initials: NF
authors.lastname: Andersen
authors.affiliation: Department of Hematology, Rikshospitalet, Oslo, Norway.
authors.forename: T G
authors.initials: TG
authors.lastname: Dahl
authors.affiliation: Department of Hematology, Aalborg University Hospital, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Gregersen
authors.affiliation: Department of Hematology, Herlev University Hospital, Herlev, Denmark.
authors.forename: T W
authors.initials: TW
authors.lastname: Klausen
authors.affiliation: Department of Hematology, Sahlgrenska University Hospital, Gothenborg, Sweden.
authors.forename: U-H
authors.initials: UH
authors.lastname: Mellqvist
authors.affiliation: Department of Hematology, Örebro University Hospital, Örebro, Sweden.
authors.forename: O
authors.initials: O
authors.lastname: Linder
authors.affiliation: Department of Hematology, Haukeland University Hospital, Bergen, Norway.
authors.forename: R
authors.initials: R
authors.lastname: Lindås
authors.affiliation: Department of Hematology, Herlev University Hospital, Herlev, Denmark.
authors.forename: N
authors.initials: N
authors.lastname: Tøffner Clausen
authors.affiliation: Department of Hematology, Skåne University Hospital, Lund, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Lenhoff
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D019172:Transplantation Conditioning / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods*
chemical_list: D000069286:Bortezomib; D003907:Dexamethasone; D008558:Melphalan