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Novel therapeutic agents provide hope for patients with hard-to-treat blood disorders
Date:12/9/2012

ne system to attack and destroy myeloma cells, but also prevents the growth of new blood vessels and inhibits myeloma cell growth by reducing the supply of oxygen and nutrients to the myeloma cells. To evaluate whether a combination regimen with pomalidomide plus low-dose dexamethasone therapy might offer relapsed multiple myeloma patients better progression-free and overall survival than high-dose dexamethasone alone, researchers conducted a study in a population of patients with refractory or relapsed and refractory disease.

The open-label, multicenter, Phase III trial evaluated the safety and efficacy of pomalidomide and low-dose dexamethasone (LoDEX) combination as compared to high-dose dexamethasone (HiDEX) alone. A total of 455 patients were enrolled and randomized to receive regimens of either pomalidomide with LoDEX (Arm A, 302 patients) or HiDEX (Arm B, 153 patients) in a 28-day cycle until disease progression or severe toxicity. The primary endpoint was progression-free survival (PFS), while secondary endpoints included measures of safety, overall survival, and quality of life.

After a median follow-up of 18 weeks, patients who received the pomalidomide and LoDEX combination experienced significantly longer PFS compared with those who received HiDEX alone (15.7 vs. 8 weeks), and overall survival was also longer in the combination treatment arm. After an independent review committee concluded that the combination regimen offered survival advantage, the study's Data Safety Monitoring Board recommended that patients from Arm B be switched to Arm A to receive the combination treatment.

The combination regimen was well tolerated among the study participants, although some expected toxicities were reported in both groups, including low neutrophil count (42% in Arm A vs. 15% in Arm B), low platelet count (21% vs. 24%), and fever (7% vs. 0%). At the time of analysis, 45 percent of patients in Arm A and 25 percent of patients in Arm
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology
Source:Eurekalert

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