( studies demonstrated that theproteaso...)Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity,and Safety Profile of Quadramet at International Myeloma Workshop,Health

studies demonstrated that the proteasome inhibitor bortezomib selectively sensitizes myeloma cells to the lethal effects of radiation from QUADRAMET, resulting in prolonged survival, reduced clonogenicity of bone marrow-resident 5TGM1 cells, reduced serum myeloma-associated paraprotein levels, and better preservation of bone mineral density. Multiple myeloma is also a highly radiosensitive skeletal malignancy, yet bone-seeking radiopharmaceuticals such as QUADRAMET have not yet found their place in either pain palliation or disease management. Accordingly, the primary objective of the Phase 1 dose escalation study was to determine safety and tolerability of the combination regimen for patients with relapsed or refractory multiple myeloma. As a secondary objective, the study is also assessing response rates.

A complete treatment cycle is eight weeks in duration and consists of injections of bortezomib on days one, four, eight and eleven with a single dose of QUADRAMET administered on day three. By way of comparison, bortezomib monotherapy is typically administered on days one, four, eight and eleven of a treatment cycle that is repeated every three weeks, typically for six to eight cycles. Patients were permitted to receive up to four treatment cycles providing their disease was stabile or responsive without undue toxicity and they continued to meet baseline eligibility criteria.

There were two parallel arms to the study. The first arm administered bortezomib at 1.0 mg/m(2) and the second arm administered bortezomib at 1.3 mg/m(2). Both arms used escalating doses of QUADRAMET (0.25 mCi/kg, 0.5 mCi/kg, and 1.0 mCi/kg). The standard approved dose of QUADRAMET for palliation of bone pain is 1.0 mCi/kg. Patients were enrolled alternately into parallel cohorts.

A summary of the poster is as follows:

-- The study enrolled 33 patients with relapsed or refractory multiple myeloma and measurable disease who overall received 60 cycles of treatment.
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