Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma

• Response Rate on Induction [ Time Frame: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days ] [ Designated as safety issue: No ]
  Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
  
  

• Response Rate on Maintenance [ Time Frame: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days ] [ Designated as safety issue: No ]
  ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.
  
  
• Response Rate on Reinduction [ Time Frame: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days ] [ Designated as safety issue: No ]
  ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.
  
  
• 1-year Progression Free Survival Probability [ Time Frame: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry ] [ Designated as safety issue: No ]
  Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.
  
  

OBJECTIVES:

Primary

• Determine the response rate in patients with newly diagnosed high-risk stage III multiple myeloma treated with bortezomib induction therapy.

Secondary

• Determine the progression-free survival of patients treated with this drug.
• Determine the response rate and duration of second response in patients who relapse or progress while on maintenance therapy and subsequently receive reinduction therapy with this drug.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression must complete at least 2 courses of induction therapy. Patients who achieve complete remission receive 2 additional courses, but no more than 8 courses total, and then proceed to maintenance therapy.
• Maintenance therapy: Patients receive bortezomib IV over 3-5 seconds on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may return to induction therapy (reinduction therapy).
• Reinduction therapy: Patients receive bortezomib as in induction therapy. Courses repeat every 3 weeks until second disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years from study entry.

ACTUAL ACCRUAL: A total of 44 patients were accrued for this study.