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Clinical Trial
. 2015 Oct;50(10):1306-11.
doi: 10.1038/bmt.2015.125. Epub 2015 Jun 29.

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

P Gimsing  1 , Ø Hjertner  2 , N Abildgaard  3 , N F Andersen  4 , T G Dahl  5 , H Gregersen  6 , T W Klausen  7 , U-H Mellqvist  8 , O Linder  9 , R Lindås  10 , N Tøffner Clausen  7 , S Lenhoff  11
Affiliations
Clinical Trial

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

P Gimsing et al. Bone Marrow Transplant. 2015 Oct.

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.

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Figures

Figure 1
Figure 1
Phase 2 study of bortezomib–dexamethasone reinduction followed by bortezomib–high-dose melphalan (HDM-Btz) with autologous stem cell support (ASCT) at first relapse after initial ASCT. Survey of included patients.
Figure 2
Figure 2
Kaplan–Meier plot of overall survival (OS), progression-free survival (PFS) and time to next treatment (TNT) from start of reinduction therapy of all included patients. The Y axis indicates the event-free survival (event=death or PD (PFS) or next treatment (TNT)).
Figure 3
Figure 3
Kaplan–Meier Plot of PFS II after salvage autologous stem cell transplantation (ASCT) compared with PFS I after initial ASCT (a) and TNT II after salvage ASCT compared with TNT I after initial ASCT (b). The Y axis indicates the event-free survival (event=death or PD (PFS) (a) or next treatment (TNT) (b)).
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