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In a randomized, open-label, phase 3 study, the use of melphalan plus prednisone (MP) either with or without the addition of bortezomib, was compared in a cohort of previously untreated Multiple Myeloma (MM) patients who were ineligible for high-dose therapy. Patients (n=682) were recruited from December 2004 to September 2006 across 151 centers worldwide. The study, published in the New England Journal of Medicine in August 2008, was led by Jesús San Miguel and Paul G. Richardson, currently based at the Clinica Universidad de Navarra, Pamplona, Spain, and The Dana Faber Cancer Institute, Boston, USA, respectively. The primary end point was time to disease progression (TTP). Secondary end points included the rate of complete response (CRR), duration of response (DoR), time to subsequent myeloma therapy, and overall survival (OS).
All data are given as bortezomib group vs control group:
In conclusion, the addition of bortezomib to the standard MP regimen for transplant-ineligible patients gave a significant 7.4-month benefit in TTP, and was observed across all patient subgroups. In addition, bortezomib did not dramatically affect the safety profile, and therefore the addition of bortezomib to MP was recommended for routine care of this patient set, at this time, and signalled a move towards triplet drug regimens.
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