Multiple Myeloma Clinical Trial
Official title:
Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
Primary Objective
• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with
newly diagnosed multiple myeloma.
Secondary Objectives
- To evaluate the tolerability and toxicity.
- To evaluate time to progression.
- To assess the frequency and severity of peripheral neuropathy.
- To evaluate the impact of early intervention with dose modification and explore
symptomatic treatment of peripheral neuropathy.
Exploratory Objectives
• To perform pharmacogenomic analysis of molecular markers associated with response or
non-response.
Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable
participants, if at least 27 objective responses are observed then bortezomib will be
considered promising. The probability of concluding the treatment promising is >0.95 with a
true ORR of 55% and <0.07 with a true ORR of 35%.
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