If a patient knew they had a high risk of developing multiple myeloma, it is likely that the patient would be willing to take a pill to eliminate that risk. That simple concept was the impetus for a trial of lenalidomide in smoldering multiple myeloma (SMM).
Sagar Lonial, MD, Chief Medical Officer at Winship Cancer Institute of Emory University, Atlanta, said patients who have been told they have smoldering multiple myeloma typically become anxious about the possibility of developing full-blown disease or take a wait-and-see attitude. “It’s gratifying to know that, especially for the first group of patients, there may now be a viable treatment option,” he said.
The E3A06 trial enrolled patients with intermediate or high-risk SMM in two phases. In phase II, 44 people received lenalidomide — which is an analogue of thalidomide — to assess potential efficacy. In phase III, investigators randomly assigned 182 people to a 25 mg pill of lenalidomide daily for 21 of the first 28 days of a therapy cycle, or observation, and stratified them based on whether they were diagnosed with high-risk SMM within that past year or more than a year after enrollment.
Lonial said that 3 years after enrollment in the phase II trial, 87% of participants were still healthy with no progression to multiple myeloma. But lenalidomide is not an easy drug to take: 80% of the people in phase II and 51% of those in phase III discontinued the medication. Still, Lonial said that balanced against the reality of multiple myeloma, a toxic therapy may appeal to many people. ASCO president Monica M. Bertagnolli, MD, cautioned, “This approach is not for everyone…because it comes with potentially heavy side effects and costs, so watching and waiting still has clear advantages that every patient should discuss with their doctor.”
Abstract 8001: E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma. The ASCO meeting, which kicks off May 31 in Chicago, will feature 2,400 abstracts, and another 3,200 submitted abstracts will be published online. Follow BreakingMED coverage at Physicians’ Weekly.
Peggy Peck, Editor-in-Chief at BreakingMED, a service of @Point of Care, LLC, which provides daily medical news reports curated to serve the unique needs of busy physicians and other healthcare professionals.