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In January 2015 Stewart K et al. from The Mayo Clinic, published the results of the ASPIRE phase 3 study in The New England Journal of Medicine. This study assessed the efficacy of a triple-drug regimen: carfilzomib (a proteasome inhibitor) plus lenalidomide and dexamethasone, for the treatment of relapsed Multiple Myeloma (MM). A total of 792 patients with relapsed Multiple Myeloma, MM were recruited between July 2010 and March 2012, and randomly assigned into two treatment groups: carfilzomib or placebo, against a background of a combined lenalidomide and dexamethasone regime. The primary end-point was progression free survival (PFS) in the intention to treat (ITT) population.
In conclusion, the addition of carfilzomib to the combination treatment of lenalidomide plus dexamethasone, resulted in a significant improvement in PFS in patients with relapsed MM. Specifically there was a 31% decreased risk of disease progression and an 8.7-month increase in median PFS. This promising outcome therefore continues the trend towards a triple drug regimen for patients with relapsed MM. Indeed, data from this trial was pivotal in driving approval of the described regimen for MM patients by both the EMA and US FDA in 2015.
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