James R. Berenson, MD, discusses a phase I/II study of pomalidomide, dexamethasone and pegylated liposomal doxorubicin for patients with relapsed/refractory multiple myeloma.
James R. Berenson, MD, Medical and Scientific Director, Institute for Myeloma & Bone Cancer Research, Chief Executive Officer, Oncotherapeutics, discusses a phase I/II study looking at pomalidomide, dexamethasone, and pegylated liposomal doxorubicin (PLD) for patients with relapsed/refractory multiple myeloma.
The phase I portion of the study enrolled patients with progressive multiple myeloma that had relapsed following stabilization with an anti-myeloma agent, such as bortezomib. Patients received pomalidomide at 2, 3, or 4 mg daily in successive cohorts on days 1 to 21 of a 28-day cycle. Dexamethasone was administered intravenously at 40 mg over 30 minutes and PLD was administered at 5 mg/m2 as an IV infusion over 30-90 minutes, both on days 1, 4, 8, and 11 of each cycle. Pomalidomide doses were escalated until the maximum tolerated dose was reached.
Berenson says that the phase II portion of the study enrolled patients who had failed treatment with within 8 weeks. In December, 20 patients had been enrolled and treated with the combination of pomalidomide, dexamethasone, and PLD. A presentation at the 2012 American Society of Hematology Meeting reported results from 10 patients showing promising response rates, although the results were still early.