FDANews

Tysabri Trial for Multiple Myeloma Gets Under Way

Elan and Biogen Idec have started a Phase I/II clinical trial of their multiple sclerosis drug Tysabri to treat multiple myeloma, a plasma cancer.

The first multiple-myeloma patient took Tysabri (natalizumab) Sept. 4. The open-label, two-arm study will evaluate the safety and potential anti-tumor activity of the drug in adult patients with relapsed or refractory multiple myeloma.

In the Phase I portion of the trial, a standard dose-escalation design will be used to assess the safety and tolerability of Tysabri in as many as 12 patients. In the Phase II portion, as many as 30 patients will be randomized to the tolerated doses identified in Phase I.

Treatment cycles will be intravenous infusions of Tysabri once every 28 days for six months. After that, patients who have had a partial or complete response may continue to receive Tysabri once every 28 days until the disease begins to progress, according to a statement from the companies.