Patients are randomized to receive 9 cycles of either VMP, VCP, or VP. Thereafter, a subsequent maintenance phase consists of V alone, administered until any sign of disease progression.
STUDY OBJECTIVES:
Primary objectives: - Determine whether Velcade-Melphalan-Prednisone (VMP), Velcade-Cyclophosphamide-Prednisone (VCP) and Velcade-Prednisone (VP) induce a significant VGPR rate in patients with newly diagnosed MM
- Determine the CR rate
- Determine the PR rate
Secondary objectives: - Determine safety
- Determine time to response and duration of response
- Determine progression free survival (PFS), time to progression (TTP), time to next treatment (TTNT) and overall survival (OS)
STUDY POPULATION:
Subjects who are ≥ 75 years old, or younger who are not eligible for high-dose therapy
STUDY DRUGS:
Bortezomib
Melphalan
Prednisone
Cyclophosphamide
TOTAL SAMPLE SIZE: 150
STUDY DURATION: 60 months