Not sure if they have released details on the design before.
Design:
o Single-arm study with a 2-stage design: after treating 9 pts in the 1st stage, if > 2 respond (a
partial response or better), the trial will continue to the 2nd stage and a total of 24 pts will be
treated
o Each pt will be treated with up to 4 cycles of PAT-SM6 (6 mg/kg/dose) + carfilzomib (20-27
mg/m2
) + dexamethasone (40 mg)
o Each cycle will consist of 3 doses of PAT-SM6, 6 doses of carfilzomib and 4 doses of
dexamethasone administered over one month
Ann: Patrys Presents at AusBiotech Invest 2014, page-3
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