Celgene points to other culprits

A letter published in The New England Journal of Medicine last week implied that Celgene Corp.'s Thalomid thalidomide was responsible for the high level of deep vein thrombosis (DVT) seen in a suspended Phase II trial of the drug in combination with doxorubicin and dexamethasone to treat multiple myeloma. But according to the company, the main culprits are both doxorubicin and the disease itself.

Investigators at the Sloan-Kettering Cancer Center in New York reported that 4 of 15 patients (27%) with newly diagnosed multiple myeloma who were treated with Thalomid, dexamethasone and doxorubicin developed symptomatic DVT in the trial, which was suspended in February (see B10). The researchers noted that another Phase II trial of Thalomid in combination with dexamethasone in myeloma patients is ongoing at the Mayo Clinic (Rochester, N.Y.) and 3 of 45 patients (7%) in that trial have had thrombotic events. ...