Safety and Efficacy of VELCADE in Relapsed and/or Refractory Multiple Myeloma Patients With Impaired Renal Function
Limited Kidney function is a condition that can result from high cancer burden on the body
and can result in increased toxicity of anti-cancer treatment. The rationale for this open
label study is to assess prospectively the safety and efficacy of bortezomib in
renal-compromised patients with multiple myeloma. The study hypothesis is that the study
drug will be safe and effective in treatment of previously-treated multiple myeloma patients
with limited kidney function. The efficacy of bortezomib will be assessed by measuring serum
M-protein and urine M-protein (monoclonal paraprotein) levels at the beginning of each
treatment cycle before the injection of the study drug. Safety will be assessed by the
monitoring of adverse events, physical examinations (including peripheral neurological
examinations), vital sign measurements, hematology and serum biochemistry tests from the
time the patient signs the informed consent form until the final /early termination visit.
Patients will be treated with bortezomib for up to eight 21-day treatment cycles Patients
enrolled in the study will be treated with bortezomib for up to eight 21-day treatment
cycles. The patients will receive intravenous injections of bortezomib on Days 1, 4, 8, and
11. The starting dose of bortezomib, which is also the standard dose in myeloma patients,
will be 1.3 mg/m2.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of safety, toxicity and tolerability Estimation of the proportion of renal-compromised multiple Myeloma patients who have received at least 1 prior line of therapy who respond to bortezomib treatment
efficacy and safety will be assessed each cycle and the last measurement will take place at 30-45 days after the last dose of Velcade.
Janssen-Ortho Inc. Clinical Trial
Janssen-Ortho Inc., Canada
United States: Institutional Review Board