Velcade for Multiple Myeloma Retreatment Clinical Trial Initiated

Millennium Pharmaceuticals has initiated EVEREST (Evaluation of Velcade Employed as Retreatment for Efficacy, Safety and Tolerability).

This is a multicenter, Phase IV clinical trial of Velcade in multiple myeloma patients who have previously responded to Velcade and relapsed following a treatment-free remission. Efficacy of retreatment with Velcade will be assessed in terms of best-confirmed M-protein response.

The open-label, clinical 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- or 1.3-mg/m2 doses of Velcade alone or in combination with dexamethasone, have had a reduction of M-protein of 50 percent or more that has lasted at least six months with a treatment-free interval of at least four months. In the EVEREST trial, the maximum number of cycles will be dependent on patient response and investigator discretion.