Gloucester Discusses Romidepsin Combination Trial Results

Gloucester Pharmaceuticals reported interim results from a Phase I/II dose-escalation study investigating the use of romidepsin in combination with Velcade and dexamethasone to treat patients with relapsed/refractory multiple myeloma.

In the first 10 patients treated, an overall response rate of 80 percent was reported, with one complete response, six partial responses and one minor response.

The dose-escalation portion of the trial has been completed, and the maximum tolerated dose was 1.3 mg/m2 of Velcade (bortezomib), 20 mg of dexamethasone and 10 mg/m2 of romidepsin. Additional patients are being accrued at the maximum tolerated dose to assess clinical activity, according to Gloucester.

The most common adverse events reported included nausea, fatigue, constipation, diarrhea and neuropathy.