Researchers conducted a randomized, open-label Phase 3 trial to evaluate the effectiveness of adding carfilzomib to lenalidomide and dexamethasone. The study included 180 patients aged 18 or older with newly diagnosed multiple myeloma who had stable disease after an autologous stem cell transplant. These patients were treated at 12 academic and clinical centers in the USA and Poland.
The primary outcome measured was progression-free survival. Over a median follow-up of 69 months, the four-year progression-free survival was 67.5% for patients receiving the combination therapy versus 38.0% for those receiving lenalidomide alone. The median progression-free survival was also longer in the combination group at 72.8 months compared to 37.3 months.
Safety data showed that neutropenia occurred in 48% of patients in the combination group versus 59% in the lenalidomide group. Thrombocytopenia was reported in 13% versus 6%. Serious adverse events occurred in 30% of the combination group compared to 23% in the lenalidomide group. Discontinuations were not reported in the provided data.
While the results support strategies for maintenance therapy intensification, readers should note that this is a primary analysis of a specific patient population. The higher rate of serious adverse events suggests caution is needed before applying these findings broadly. Funding was provided by Amgen and Celgene.