Millennium Pharmaceuticals, Inc, recently announced the presentation of results from three phase III investigations of bortezomib used in various combinations, for initial treatment of patients with multiple myeloma. Data from these trials were selected for oral presentations at the American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, December 8–11, 2007.
VISTA Trial: Highest Reported Complete Remission Rate Achieved in Multiple Myeloma
The 682-patient, randomized, phase III VISTA trial (Velcade as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone). The trial compared VcMP (bortezomib [Velcade], melphalan [Alkeran], and prednisone) to MP (melphalan and prednisone) alone, a recognized standard of care in this treatment setting. Patients in the study had previously untreated multiple myeloma and were ineligible for stem cell transplantation.
"The goal of therapy is long-term survival, and complete remission is a well-known indicator for survival," said Professor Jesus San-Miguel, MD, Hematology Department Head, University Hospital of Salamanca and principal investigator of the trial. "Data from this rigorously controlled trial clearly show that Velcade-based therapy should be a standard of care for previously untreated patients who are not able to receive stem cell transplantation."
Data from the large international clinical trial were presented by Professor San-Miguel. Responses were evaluated by the commonly used M-protein levels measured in serum or urine by a centralized laboratory as well as the most stringent European Group for Blood and Marrow Transplantation (EBMT) criteria. Among the findings:
• Immunofixation-negative complete remission (CR) rate of 35% in the VcMP arm compared to 5% with MP (P < .000001); EBMT criteria showed a CR rate of 30% in the VcMP arm compared to 4% with MP.
• The median duration of response was 24 months for patients with CR in VcMP compared to 13 months with MP.
• Time-to-disease progression (TTP) in the VcMP arm of 24 months compared to 17 months with MP (P = .0000001)