The Phase II, multi-center, randomized, double-blind, placebo-controlled study is designed to assess the safety and efficacy of multiple doses of ACE-011 in multiple myeloma patients with osteolytic bone lesions.
The study will be a multi-center trial conducted in Russia and patients will be treated with standardized anti-myeloma therapy consisting of melphalan, prednisone and thalidomide and randomized to receive either monthly doses of ACE-011 or placebo for up to three months. This study is funded in part by a grant from the Multiple Myeloma Research Foundation.
Matthew Sherman, chief medical officer of Acceleron, said: “We have encouraging results from Phase I studies with ACE-011, and believe that it holds promise as a novel bone-forming agent to treat the serious and debilitating effects of bone loss resulting from progression of tumors in myeloma or other cancers. Acceleron plans to present results from the Phase I studies at scientific and medical conferences later in 2008.”