Multiple Myeloma Coverage from Every Angle

Smoldering Multiple Myeloma: Treat With Lenalidomide or Observe?

By: Cordi Craig
Posted: Monday, April 20, 2020

For patients with smoldering multiple myeloma, the current standard of care has been observation. However, Sagar Lonial, MD, of Emory University, Atlanta, and colleagues reported that early intervention with lenalidomide may delay disease progression and development of end-organ damage, according to the results of a phase III trial. The findings were published in the Journal of Clinical Oncology.

“This trial represents a paradigm shift in hematologic malignancies,” Dr. Lonial and colleagues stated. “We have demonstrated that early intervention with prevention does prevent the development of organ damage and symptoms, with a 72% risk reduction in more than 2 years compared with the control arm.”

The research team randomly assigned 182 patients with intermediate- or high-risk smoldering multiple myeloma to undergo observation (n = 90) or treatment with single-agent lenalidomide (n = 92). Lenalidomide treatment or observation was continued until disease progression, toxicity, or patient withdrawal from the trial. The median follow-up was 35 months.

Half of the patients in the lenalidomide arm responded to therapy, whereas none of the patients responded in the observation arm. In addition, progression-free survival was significantly longer in patients treated with lenalidomide than in those who underwent surveillance (P = .002). The 1-, 2- and 3-year progression-free survival rates were 98%, 93%, and 91% in the lenalidomide group versus 89%, 76%, and 66% in the observation group, respectively.

As for side effects, the researchers did not observe any negative impacts on health-related quality of life in those treated with lenalidomide, and the toxicity profile was consistent with that of previous clinical studies. The researchers reported grade 3 or 4 nonhematologic adverse events in 25 patients (28%) who were treated with lenalidomide. Overall, six deaths were reported: two in the lenalidomide arm and four in the observation arm.

Disclosure: For full disclosures of the study authors, visit

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