Phase II Trial Shows Gentium’s Defibrotide Active in Multiple Myeloma
Gentium announced data from an ongoing Phase I/II trial that support the safety, activity, synergy and potential mechanism of action of Defibrotide in combination with anticancer therapy in multiple myeloma.
The multicenter clinical trial for relapsed or refractory multiple myeloma patients is designed to find the maximum tolerated dose of Defibrotde. It also will test the safety and potential efficacy of the combination of melphalan, prednisone, thalidomide and Defibrotide (MPTD), Gentium said.
Nineteen patients who received at least three cycles of were evaluated for toxicity and response. After three escalating dose-levels, the major response rate, including complete and partial remission, was 53 percent, and responses were seen in all three Defibrotide dose levels, the company said.
Hematological toxicities included neutropenia (47 percent), thrombocytopenia (10 percent) and anemia (21 percent). No significant peripheral neuropathy has been reported, the company said.