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Autologous stem cell transplantation (ASCT) versus ASCT followed by reduced-intensity conditioning (RIC) allogeneic SCT with identical sibling donor in previously untreated multiple myeloma (MM): a prospective controlled trial by the EBMT.(Working Party Session Chronic leukaemias)

Beksac, M ; Musto, P ; Iacobelli, S ; Volin, L ; Narni, F ; Hegenbart, U ; Morris, C ; Gahrton, G ; Gruber, A ; Bjorkstrand, B ; de Witte, T ; Niederwieser, D ; Greinix, H ; Bosi, A ; Goldschmidt, H ; Corradini, P ; Milone, G

BONE MARROW TRANSPLANTATION, 2009, Vol.43 (S1), p.S31 [Periódico revisado por pares]

Nature Publishing Group

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  • Título:
    Autologous stem cell transplantation (ASCT) versus ASCT followed by reduced-intensity conditioning (RIC) allogeneic SCT with identical sibling donor in previously untreated multiple myeloma (MM): a prospective controlled trial by the EBMT.(Working Party Session Chronic leukaemias)
  • Autor: Beksac, M ; Musto, P ; Iacobelli, S ; Volin, L ; Narni, F ; Hegenbart, U ; Morris, C ; Gahrton, G ; Gruber, A ; Bjorkstrand, B ; de Witte, T ; Niederwieser, D ; Greinix, H ; Bosi, A ; Goldschmidt, H ; Corradini, P ; Milone, G
  • Assuntos: Care and treatment ; Medicin och hälsovetenskap ; Multiple myeloma ; Stem cells ; Transplantation
  • É parte de: BONE MARROW TRANSPLANTATION, 2009, Vol.43 (S1), p.S31
  • Descrição: 360 myeloma patients from 22 centres that had undergone HLA typing were included in the trial. Study inclusion was at the time of conditioning for first autologous transplant at the achievement of a response status of at least stable disease after VAD-like induction treatment of previously untreated patients. Patients with an HLA-identical sibling were allocated to the auto+allo (AuAl)-arm (n = 110) and patients without a matched sibling donor to the auto (Au)-arm (n = 250). In the latter cohort, single or tandem autografting was optional and 122 patients had a tandem transplant. Conditioning for ASCT was melphalan 200 mg/[m.sup.2], and for allo RIC fludarabine 30 mg/[m.sup.2] x 3 plus TBI 2 Gy. The accrual period was from February 2001 to February 2005, and median follow-up time is 54 months. The two treatment groups were well matched for the standard prognostic parameters such as beta-2-microglobulin, karyotype (del13 or not), gender, MM subtype, stage, albumin, creatinin, calcium and response status at transplantation. Median age at transplantation was significantly higher in the Au-arm (57 vs 53 years). The following results are based on intention-to-treat analyses. The CR rate was 44% in the AuAl-arm and 38% in the Au-arm (p = 0.32). Cumulative 24 mo non-relapse-mortality (NRM) was 12% in the AuAl- and 5% in the Au-arm (p = 0.012). At 60 mo after transplantation, outcomes for the two arms were as follows: Relapse rate 45% and 71% (p = 0.00078), OS 65% and 58%, and PFS 39% and 21% for the AuAl- and Au-arms, respectively; p-values for OS and PFS can not be given since these curves crossed at an earlier time point. In patients positive for del-13, OS was 65% and 52%, and PFS 32% and 8% for the AuAl- and Au-arms, respectively. The corresponding figures for patients without del-13 was OS 70% vs 52% and PFS 47% vs 22%. None of the survival differences in these subgroup analyses were statistically significant. Relapse rates were significantly lower in the AuAl-arms of both subgroups, and the curves formed a plateau from 40 mo onwards, in contrast to the Au-arm where no plateaus were observed. We conclude that the risk for myeloma relapse was significantly lower, and furthermore stabilized, in the AuAl-treatment group in comparison to ASCT only, both in the total cohort and in the poor (del-13) and better (no del-13) prognosis subgroups. NRM was significantly lower in the Au-group, but still on an acceptable level in both treatment arms. These results are reflected in a tendency for improved outcome in terms of OS and PFS.
  • Editor: Nature Publishing Group
  • Idioma: Inglês
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