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ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03),Reports Lenalidomide Plus Low-Dose Dexamethasone Suggests Survival,Advantage for Patients with Multiple Myeloma

SUMMIT, N.J., April 04, 2007 /PRNewswire-FirstCall/ -- Celgene Corporation announced that the Eastern Cooperative Oncology Group (ECOG) has reported that its Data Monitoring Committee's (DMC) review of preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma has found that the use of a low dose of dexamethasone (Decadron) in combination with lenalidomide suggests survival advantage for patients when compared to the higher, standard-dose of dexamethasone that is used in combination with lenalidomide to treat the disease.

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 also 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.

WARNINGS:

1. POTENTIAL FOR HUMAN BIRTH DEFECTS.

LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. FEMALES SHOULD BE ADVISED TO AVOID PREGNANCY WHILE TAKING REVLIMID(R) (lenalidomide).

                       Special Prescribing Requirements

BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO REVLIMID(R) (lenalidomide), REVLIMID(R) (lenalidomide) IS ONLY AVAILABLE UNDER A SPECIAL RESTRICTED DI
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