International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
Multiple myeloma is uniformly fatal. Responses achieved after multiple lines of therapy are
normally of short duration. Therefore, all patients with multiple myeloma will eventually
relapse, having become refractory to therapy and subsequently will die of their cancer. The
rationale of this study is that bortezomib as a novel agent may allow additional periods of
response due to its different mechanisms of action. This is an open-label, single-arm,
multicenter, non-comparative study to provide expanded access to bortezomib to patients with
multiple myeloma that have received at least two previous lines of therapy and are
refractory to or have relapsed after their last treatment. Patients will receive treatment
with bortezomib 1.3 mg/m2 on day 1, 4, 8 and 11 of a 3-week cycle. No treatment will be
administered on the last 10 days of each cycle. Treatment may be repeated for up to 8 cycles
with possible extension if patient is still responding at the end of the 8 cycle period.
Bortezomib 1.3 mg/m2 will be administered as an IV bolus
Observational
Time Perspective: Prospective
Janssen-Cilag International NV Clinical Trial
Study Director
Janssen-Cilag International NV
Belgium: Ministry of Social Affairs, Public Health and the Environment
CR002185
NCT00440635
January 2004
October 2006
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