High‐dose idarubicin, cyclophosphamide and melphalan as conditioning for autologous stem cell transplantation increases treatment‐related mortality in patients with multiple myeloma: results of a randomised study

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Abstract
Summary: We conducted a randomised trial comparing an intensified versus a standard conditioning regimen for high‐dose chemotherapy followed by autologous stem‐cell transplantation in patients with multiple myeloma. In this study, 56 patients were randomly assigned for high‐dose therapy with melphalan 200 mg/m2 or with idarubicin 42 mg/m2, melphalan 200 mg/m2 and cyclophosphamide 120 mg/kg. The primary objective was response rate. Acute toxicity, mainly because of infections, was higher in the intensified treatment arm with a treatment‐related mortality of 20%versus 0% in the standard arm. This lead to the early discontinuation of the study. Response rates did not differ significantly between both treatment arms {intensified versus standard: complete response + near complete remission 50% [95% confidence interval (CI) 26–74%] vs. 33% (95% CI 17–55%), partial remission 35% (95% CI 16–61%) vs. 50% (95% CI 30–70%)}. After a follow‐up of 5 years, the median time‐to‐progression and overall survival were not significantly different between both patient groups. Analysis restricted to patients surviving the first 100 d after transplant showed a better outcome for patients with ≥2 bad prognostic risk factors in the intensified treatment arm, however all treatment‐related deaths occurred within this group of patients. In conclusion, intensified conditioning for high‐dose therapy had intolerably high toxicity without improving outcome in patients with multiple myeloma.

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