Haematologica
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Haematologica, Vol 92, Issue 7, 928-935 doi:10.3324/haematol.11168
Copyright © 2007 by Ferrata Storti Foundation
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Multiple Myeloma

Intermediate-dose melphalan compared with myeloablative treatment in multiple myeloma: long-term follow-up of the Dutch Cooperative Group HOVON 24 trial

Pieter Sonneveld, Bronno van der Holt, Christine M. Segeren, Edo Vellenga, Alexandra J. Croockewit, Gregor E.G. Verhoef, Jan J. Cornelissen, Martijn R. Schaafsma, Marinus H.J. van Oers, Pierre W. Wijermans, Petra H.M. Westveer, Henk M. Lokhorst

From Erasmus Medical Center Rotterdam (Erasmus MC) and University Medical Center Utrecht (UMCU) for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON), The Netherlands

Correspondence: Pieter Sonneveld, MD, Erasmus MC, Dept. of Hematology, Rm L 407, Dr Molewaterplein 40, PO box 2040 3000 CA Rotterdam, The Netherlands. E-mail: p.sonneveld{at}erasmusmc.nl

Background and Objectives: The Dutch-Belgian HOVON group performed a randomized phase 3 trial to compare single non-myeloablative intensive treatment with double, intensive treatment in previously untreated patients with multiple myeloma (MM).

Design and Methods: Three hundred and three patients with stage II/III MM were randomized after VAD induction chemotherapy to receive two cycles of non-myeloablative intermediate-dose melphalan (70 mg/m2) (single treatment) or the same regimen followed by cyclophosphamide 120 mg/kg iv plus total body irradiation (TBI) 9 Gy and autologous stem cell transplantation (double, intensive treatment). In both treatment arms interferon {alpha}IIa was given as maintenance until relapse/progression.

Results: A significantly higher proportion of patients achieved a complete remission (CR) on protocol treatment with double, intensive therapy (32% vs 13%, p<0.001). Double treatment produced better outcome in terms of event-free survival (median 22 vs 21 months, 28% vs 14% at 4 years and 15% vs 7% at 6 years after randomization; logrank p=0.013; univariate HR 0.74, 95% CI, 0.58–0.94), progression-free survival (median 27 vs 24 months, 33% vs 16% at 4 years, and 17% vs 9% at 6 years after randomization; logrank p=0.006; HR=0.71, 95% CI 0.56–0.91), but not overall survival (median 50 vs 55 months, 52% vs 56% at 4 years and 39% vs 36% at 6 years after randomization; logrank p=0.51; HR=1.10, 95% CI 0.83–1.46). The achievement of a CR had a favorable prognostic impact on event-free survival (HR=0.60, 95% CI=0.44–0.82, p=0.001) and progression-free survival (HR=0.62, 95% CI=0.45–0.84, p=0.002).

Interpretation and Conclusions: Double, intensive treatment resulted in a better CR rate, event-free survival and progression-free survival but not overall survival compared to single non-myeloablative treatment in previously untreated patients with multiple myeloma.

Key words: intermediate dose, melphalan, myeloablative treatment, HOVON 24 trial.




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