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A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose.
Primary objectives:
• To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma.
Secondary objectives:
* To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.
* To evaluate the efficacy of ODX on serum biomarkers (M-protein, FLC, CTX, osteocalcin, and bone-specific S-ALP) in subjects with relapsed/refractory multiple myeloma.
Exploratory objective
• To evaluate time to progression by following M-protein and FLC levels as per clinical routine
A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
A randomized, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases
100 Clinical Results associated with Dextech Medical AB
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100 Translational Medicine associated with Dextech Medical AB