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news.Millennium Pharmaceuticals has initiated a phase IV clinical trial of its Johnson & Johnson co-developed drug Velcade in multiple myeloma patients who have previously responded to the treatment and relapsed following a treatment-free remission.
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The trial, named EVEREST, is a multi-center clinical trial that will assess the efficacy of retreatment with Velcade (bortezomib) for injection in terms of best confirmed M-protein response.
The trial will be conducted at approximately 80 sites in North America and will enroll up to approximately 120 patients. Eligible patients need to have tolerated 1.0 or 1.3mg/m2 doses of Velcade alone or in combination with dexamethasone (Merck & Co’s Decadron), and have had a reduction of M-protein of 50% or more that has lasted at least six months with a treatment-free interval of at least four months.
“Velcade has proven efficacy in patients with relapsed and refractory myeloma, with responses lasting approximately one year,” said Dr David Schenkein, senior vice president of clinical research at Millennium. “There is no known mechanism of resistance to Velcade, and no new cumulative toxicity with extended therapy, so we are optimistic about the benefits of retreatment which would allow patients to receive multiple lines of therapy with Velcade.”