A phase III trial put standard therapy for multiple myeloma to the test against a trio of novel drug agents in young patients and proved itself to be more effective, according to an abstract presented at the 2011 European Multidisciplinary Cancer Congress in Stockholm.
Slightly more than 400 patients were randomized to receive standard therapy—autologous stem cell transplantation plus melphalan—or lenalidomide (Revlimid) plus melphalan and prednisone.
The trial was carried out by researchers out of the University of Turin in Italy.
After 26 months, progression-free survival (PFS) for patients in the transplant arm was 73%, compared with just 54% in patients receiving the trio of drugs.
Complete remission between the two groups was comparable: 20% of patients in the drug arm achieved complete remission, while 25% in the transplant arm achieved complete remission. This was also seen in the 18 month overall survival, with 91% in the drug arm and 95% in the transplant arm, although researchers noted that a longer follow-up was necessary to assess overall survival.
There were fewer instances of grade 3 or 4 toxicity in the drug arm than in the transplant arm, but the trial results suggest that for this patient population, autologous stem cell transplantation plus melphalan remains a reliable standard.
Palumbo A, et al "A phase 3 study comparing melphalan-prednisone-lenalidomide with high-dose melphalan and autologous transplantation in newly diagnosed patients with multiple myeloma" Eur J Cancer 2011; Abstract 9200: pS639.
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