E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma
Smoldering multiple myeloma (SMM) is a precursor to myeloma. Observation is its current standard of care. Data from a randomized Spanish trial (Mateos et al, NEJM 2015) suggests that lenalidomide/dexamethasone improves time to developing myeloma (TTP) and overall survival (OS) for patients with high-risk (HR) SMM under observation. However, patients who were not screened with advanced imaging techniques used a high-risk definition that is not routinely available along with combination therapy, which limited the ability to isolate the effect of lenalidomide.Thus, this protocol has not become a standard of care.
Overall, this trial represents the largest randomized trial in SMM to date. In conjunction with the Spanish data, this trial may support a change in clinical practice.
Sagar Lonial, Susanna J. Jacobus, Matthias Weiss, Shaji Kumar, Robert Z. Orlowski, Jonathan L. Kaufman, Abdulraheem Yacoub, Francis Buadi, Timothy E. O'Brien, Jeffrey Matous, Daniel M. Anderson, Robert Emmons, Madhav V. Dhodapkar, Lynne I. Wagner, S. Vincent Rajkumar; Winship Cancer Institute of Emory University, Atlanta, GA; Dana-Farber Cancer Institute, Boston, MA; ThedaCare, Appleton, WI; Mayo Clinic, Rochester, MN; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Kansas Cancer Center, Westwood, KS; Division of Hematology, Mayo Clinic, Rochester, MN; MetroHealth Medical Center/Case Western Reserve University School of Medicine, Cleveland, OH; Colorado Blood Cancer Institute, Denver, CO; Regions Hospital, St Paul, MN; Ochsner Cancer Institute, New Orleans, LA; Yale School of Medicine, New Haven, CT; Northwestern University Feinberg School of Medicine, Chicago, IL
Clinical trial information:
ASCO 2019 Abstract No: 8001
J Clin Oncol 37, 2019 (suppl; abstr 8001)
ABOUT SAGAR LONIAL, MD, FACP
Dr. Sagar Lonial is Chief Medical Officer at the Winship Cancer Institute at Emory University in Atlanta. He is board certified in hematology and medical oncology. His research focus is "with combinations of novel agents as therapy for myeloma and lymphoma, particularly evaluating combinations that may result in synergistic inhibition of the PI3-K/Akt pathway." Visit Dr. Sagar Lonial's full biography.