Dec 19, 2009
Revlimid Meets Primary Endpoint In A Phase III Study
The initial data from a Phase III study using the Revlimid in multiple myeloma patients who had undergone stem cell transplant reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression.
The investigational study evaluated Revlimid compared to placebo in multiple myeloma patients following autologous stem cell transplant, and the independent Data and Safety Monitoring Board reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression.
The Phase III, randomized, double-blind, multi-center clinical study was led by the Cancer and Leukemia Group B, or CALGB, and the independent Data and Safety Monitoring Board reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression. The study was sponsored by the National Cancer Institute under a Clinical Trials Agreement with Celgene.
Revlimid, in combination with dexamethasone, is already indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
The Revlimid pivotal MM-015 trial exceeded pre-specified interim efficacy endpoint in newly diagnosed Multiple Myeloma. Further results from the study will be presented in a peer-reviewed setting in 2010.
