Autologous haematopoietic stem-cell transplantation versus bortezomib–melphalan–prednisone, with or without bortezomib–lenalidomide–dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study

This open-label RCT (n=1197) found median progression-free survival was longer with autologous HSCT compared with bortezomib–melphalan–prednisone as intensification therapy (56.7 months [95% CI 49.3-64.5] vs 41.9 months [37.5-46.9]; HR 0.73, 0.62-0.85; p=0.0001).

SPS commentary:

The study also compared bortezomib–lenalidomide–dexamethasone (VRD) consolidation therapy with no consolidation, and reported a benefit for VRD in terms of progression-free survival (58.9 months [54.0–not estimable] vs 45.5 months [39.5–58.4]; HR 0.77, 0.63-0.95; p=0.014). The number of events at the time of data analysis were however lower than pre-planned for the final analysis, and this represents results from the second analysis (when 66% of events reached).

The Lancet Haematology