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Celgene Corp Announces Phase III Study (MM-003) Of Pomalidomide Plus Low-Dose Dexamethasone

Tuesday, 11 Dec 2012 08:45am EST 

Celgene Corp announced that Celgene International Sàrl, a subsidiary of Celgene Corporation announced data from phase III, multi-center, randomized (2:1), open-label study (MM-003, n=455) of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination. MM-003 met the primary endpoint of improvement in progression-free survival (PFS). PFS was significantly longer in patients who received pomalidomide plus low-dose dexamethasone compared with those who received high-dose dexamethasone (median 3.6 months vs. 1.8 months; hazard ratio HR, 0.45; P < 0.001). According to the study design, an interim analysis of overall survival (OS) was also conducted. In this analysis, pomalidomide plus low-dose dexamethasone demonstrated a highly statistically significant improvement in overall survival that crossed the upper boundary for superiority (median OS not reached vs. 7.8 months; HR, 0.53; P < 0.001). As a result, the Data Monitoring Committee recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed over to pomalidomide plus low-dose dexamethasone. 

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