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Patients Given Choice to Switch to Lenalidomide Treatment Arm in Phase 3 SWOG Trial

SUMMIT, N.J., May 15 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced that the Southwest Oncology Group (SWOG) has permanently closed enrollment in a federally funded clinical trial. The Phase III randomized controlled study (S0232) compared a standard drug therapy, dexamethasone, with a combined therapy of dexamethasone plus Revlimid (lenalidomide) for patients newly diagnosed with multiple myeloma. Additionally, SWOG announced that current participants in the SWOG study, S0232, be given the choice of switching to REVLIMID with dexamethasone. The SWOG data and safety monitoring committee based its recommendation to permanently close enrollment on the preliminary one year survival results from the Eastern Cooperative Oncology Group (ECOG) Phase III study (E4A03). The ECOG study is evaluating the use of a low dose of dexamethasone in combination with lenalidomide as compared to the higher, standard-dose of dexamethasone that is used in combination with lenalidomide to treat patients newly diagnosed with multiple myeloma.

According to SWOG, the 198 patients enrolled in the trial, prior to the closure, are sufficient to provide data analysis and evaluate the primary endpoint of progression-free survival (PFS) in the two arms of the trial. Data analysis is ongoing and results will be presented and released in the usual fashion.

Revlimid(lenalidomide) is approved by the U.S. Food and Drug Administration for use as a treatment in combination with standard-dose dexamethasone for patients with multiple myeloma who have received at least one prior therapy. Revlimid is approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid recently received a positive opinion from the European Medicines Agency (EMEA) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

Source: Celgene Corporation

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