| Objectives |
Primary
Objectives of Phase I
- Establish the safety of
the combination of ATN 224 and bortezomib
- Determine the dose of
ATN-224 and bortezomib to be used in the Phase II portion of the
study
Secondary
Objectives of Phase I
- Describe the effects of
the combination on potential biomarkers of activity including
superoxide dismutase (SOD), circulating endothelial cells (CECs) and
endothelial progenitor cells (EPCs) and pleiotrophin
- Obtain preliminary
evidence of efficacy of the combination in adult patients with
myeloma relapsed from or refractory to bortezomib as evidenced by
clinical benefit response. Response (complete, partial and minor),
stable disease and progressive disease will be determined by the
criteria of the European Bone Marrow Transplantation group. Clinical benefit response will include the
rate of complete, partial and minor response and stable disease for
at least 12 weeks.
- Characterize the plasma
concentrations of ATN-224 in combination with bortezomib
Primary
Objective of Phase II
- In patients with
myeloma relapsed from or refractory to bortezomib, obtain
preliminary evidence of efficacy as evidenced by clinical benefit
response.
Secondary
Objectives of Phase II
- Establish the safety of
the combination of ATN-224 and bortezomib in this patient population
- Estimate the
progression-free survival and duration of response distributions
- Explore the correlation
of biomarkers with response to therapy
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