Lenalidomide Beats Standard of Care in Smoldering MM

Samantha DiGrande

As a precursor to myeloma, smoldering multiple myeloma currently has no treatment. In fact, the standard of care is observation until the patient starts to present with symptoms. However, according to new research that will be presented at the American Society of Clinical Oncology’s annual meeting in Chicago, Illinois, held May 31 to June 4, early treatment of smoldering multiple myeloma may delay progression to full-blown disease.

Results from a randomized phase 3 trial suggest that lenalidomide improves the time to developing multiple myeloma as well as overall survival for patients with high risk smoldering multiple myeloma. For patients who received early treatment with lenalidomide, 3-year progression-free survival was 91%, compared with 66% for patients who were only followed with observation.

The results were presented in a press briefing prior to the start of the meeting.

“It’s pretty clear that smoldering myeloma is a heterogeneous group of patients. What’s really interesting is that every risk group appeared to benefit from early intervention,” the lead author, Sagar Lonial, MD, professor and chair, Department of Hematology and Medical Oncology, Emory University School of Medicine, said during the call.

The trial enrolled 182 patients and randomized them to receive either lenalidomide (n = 90) or observation (n = 92). Fatigue was the most common adverse event (n = 5), followed by neutropenia (n = 4) in the lenalidomide arm. The overall response rate was 48.9% for the patients treated with lenalidomide, and 0% for the observation arm.

Overall, the researchers found that “this trial represents the largest randomized trial in smoldering multiple myeloma to date.” In conjunction with data from a previous study, this trial “may support a change in clinical practice”; however, more data are needed to confirm the conclusion.

Lonial S, Jacobus S, Weiss M, et al. Randomized phase 3 trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma. To be presented at the American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 8001.
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