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Haematologica, Vol 91, Issue 4, 542-545
Copyright © 2006 by Ferrata Storti Foundation

Clinical Trial, Phase I

Dose-finding study of high-dose simvastatin combined with standard chemotherapy in patients with relapsed or refractory myeloma or lymphoma

E van der Spek, AC Bloem, NW van de Donk, LH Bogers, R van der Griend, MH Kramer, O de Weerdt, S Wittebol, and HM Lokhorst

Department of Hematology and Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands.

In vitro statins induce apoptosis in myeloma and lymphoma cells in a dose-and time-dependent way. In combination with dexamethasone and doxorubicin, statins have a chemo-sensitizing effect. Twenty-eight patients with relapsed myeloma or lymphoma were treated with a dose-escalating regimen of simvastatin for 7 days followed by VAD in myeloma patients and CHOP in lymphoma patients. The maximum tolerated dose was 15 mg/kg/day simvastatin. The most frequently reported side-effects were fatigue, gastrointestinal CTC grade 1-2 and neutropenic fever. The dose-limiting toxicity was neutropenic sepsis and grade 3 gastrointestinal side effects. High-dose simvastatin given immediately prior to chemotherapy is safe and tolerable up to a dose of 15 mg/kg/day.


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