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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.

Gimsing, P ; Hjertner, Ø ; Abildgaard, N ; Andersen, N F ; Dahl, T G ; Gregersen, H ; Klausen, T W ; Mellqvist, U-H ; Linder, O and Lindås, R , et al. (2015) In Bone Marrow Transplantation 50(10). p.1306-1311
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... (More)
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.Bone Marrow Transplantation advance online publication, 29 June 2015; doi:10.1038/bmt.2015.125. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Bone Marrow Transplantation
volume
50
issue
10
pages
1306 - 1311
publisher
Nature Publishing Group
external identifiers
  • pmid:26121108
  • wos:000362497400007
  • scopus:84943448338
ISSN
1476-5365
DOI
10.1038/bmt.2015.125
language
English
LU publication?
yes
id
5d1e0412-dd5d-48fe-bd06-673cfe97b089 (old id 7477390)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/26121108?dopt=Abstract
date added to LUP
2016-04-01 10:19:51
date last changed
2024-10-07 02:10:33
@article{5d1e0412-dd5d-48fe-bd06-673cfe97b089,
  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.Bone Marrow Transplantation advance online publication, 29 June 2015; doi:10.1038/bmt.2015.125.}},
  author       = {{Gimsing, P and Hjertner, Ø and Abildgaard, N and Andersen, N F and Dahl, T G and Gregersen, H and Klausen, T W and Mellqvist, U-H and Linder, O and Lindås, R and Tøffner Clausen, N and Lenhoff, Stig}},
  issn         = {{1476-5365}},
  language     = {{eng}},
  number       = {{10}},
  pages        = {{1306--1311}},
  publisher    = {{Nature Publishing Group}},
  series       = {{Bone Marrow Transplantation}},
  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.}},
  url          = {{https://lup.lub.lu.se/search/files/1753411/8820731}},
  doi          = {{10.1038/bmt.2015.125}},
  volume       = {{50}},
  year         = {{2015}},
}