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news.Onyx Pharmaceuticals has started enrollment in Phase 3 Kyprolis trial versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.
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The RandomizEd, OpeNLabel, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma (ENDEAVOR) trial is an 888 patient study.
Onyx Pharmaceuticals Research and Development and Technical Operations executive vice president Ted Love said the ENDEAVOR trial is the first head-to-head trial conducted with Kyprolis, and is an important step in the development program
"The initiation of this trial underscores our commitment to patients with multiple myeloma who are in need of new treatment options beyond the currently available therapies," Love added.
The progression-free survival is the primary endpoint while overall survival, overall response rate, duration of response, and safety comprise the secondary endpoints.
Patients will be randomized to receive Kyprolis intravenously (20mg/m(2) on days 1 and 2 of cycle 1 only, then 56 mg/m(2) subsequently) with low-dose dexamethasone (20mg), versus bortezomib (1.3 mg/m(2)) with low-dose dexamethasone.
At the discretion of the investigator and in accordance with regulatory approval of bortezomib, it can be administered subcutaneously or intravenously.