Lenalidomide reduced the risk of disease progression among patients with intermediate- or high-risk smoldering multiple myeloma, according to data from the phase 2/3 E3A06 clinical trial. The trial results will be presented at the upcoming 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The trial had a phase 2/3 design and enrolled patients with intermediate- or high-risk smoldering multiple myeloma. For the phase 2 portion, a single group of 44 patients received lenalidomide.

Once the safety of lenalidomide was demonstrated in the phase 2 portion, a phase 3 study was conducted, and patients were randomly assigned to either the lenalidomide arm (90 patients) or observation arm (92 patients). Patients enrolled in the intervention arm received lenalidomide 25 mg orally each day for 21 days of the first 28 days of a treatment cycle.

In the phase 2 portion of the trial, 87% of participants were still alive without disease progression at 3 years of follow-up. In the randomized phase 3 portion, 91% of patients remained alive without disease progression in the lenalidomide arm compared with 66% in the observation arm at 3 years of follow-up.