Celgene has announced results from an open-label phase II/III study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI).

ECOG E3A06 is a randomised study evaluating the safety and efficacy of the investigational use of Revlimid monotherapy versus observation in patients with asymptomatic smoldering multiple myeloma. In the study, single-agent Revlimid achieved a statistically significant improvement in the primary endpoint of progression-free survival compared to observation.

“In multiple myeloma, there has been an important question regarding the risks and benefits of treating patients with smoldering myeloma. We believe that the properties of Revlimid could play an important role in delaying the progression of smoldering myeloma into active myeloma,” said Jay Backstrom, Chief Medical Officer for Celgene.

Based on the preliminary results of the study, safety was consistent with the known safety profile of Revlimid.

Data from ECOG E3A06 will be presented at a future medical meeting.