Revlimid Phase III enrollment suspended

Celgene (CELG) said enrollment of a Phase III trial (ECOG Study) of Revlimid lenalidomide to treat multiple myeloma (MM) was suspended until the end of October in order to change the trial protocol. All patients will now receive baby aspirin in addition to Revlimid plus dexamethasone. The 250 patients enrolled to date will continue treatment and will immediately start receiving aspirin. The double-blind trial will enroll about 400 patients. Data are expected in the first half of 2007.

CELG said the change is in response to an study published last month in Blood, which showed that only 3% of patients experienced deep vein thrombosis (DVT) when given aspirin plus Revlimid and dexamethasone in a Phase II MM trial. The same article said that two previous Phase III trials of Revlimid plus dexamethasone without aspirin showed a 9-15% incidence of DVT. ...