The 2008 approval was based on an international, multicenter, open label, active-control trial in previously untreated people with symptomatic multiple myeloma. People were randomized to receive either nine cycles of oral melphalan (M) plus prednisone (P) or MP plus bortezomib. People received M (9 mg/m2 ) plus prednisone (60 mg/m2 ) daily for four days every 6 weeks or the same MP schedule with bortezomib, 1.3 mg/m2 iv on days 1, 8, 11, 22, 25, 29, and 32 of every 6 week cycle for 4 cycles then once weekly for 4 weeks for 5 cycles. Time- to- progression (TTP) was the primary efficacy endpoint. Overall survival (OS), progression-free survival (PFS), and response rate (RR) were secondary endpoints. Eligible people were age > 65 years. A total of 682 people were randomized: 338 to receive MP and 344 to the combination of bortezomib plus MP. Demographics and baseline disease characteristics were similar between the two groups.