Lenalidomide Proves Effective in Treating Smoldering Multiple Myeloma

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A new study by Mayo Clinic Researchers calls into question the current standard of care for treating smoldering multiple myeloma.

The cancer drug lenalidomide can delay the symptoms of myeloma, leading to delayed disease progression and preventing organ damage, according to a new study presented at the 2019 American Society of Clinical Oncology Annual Meeting.

The findings call into question the current standard of care for smoldering multiple myeloma (SMM), which is simply observation and no therapy.

"At present, the standard of care for smoldering multiple myeloma is observation without therapy," S. Vincent Rajkumar, MD, a Mayo Clinic hematologist and senior author of the trial, said in a statement. "We found that treatment of smoldering myeloma delays progression to symptomatic myeloma and can prevent damage to organs that occurs in multiple myeloma."


The findings of the study, which is the largest randomized trial of SMM to date, aligns with a smaller 2015 Spanish study involving lenalidomide and dexamethasone. In the 2019 study, 28% of participants experienced serious adverse events. However, investigators said the events were considered manageable.

The study did not make clear if the benefits were the result of one drug or a combination of both.

The study included 182 individuals, with 92 receiving the lenalidomide. The remaining 90 participants were simply observed, as is the current standard clinical practice. Nearly half of the patients taking lenalidomide responded to the treatment. Patients who were not taking the drug showed no change.

"We show that it is possible to delay progression to multiple myeloma, a serious cancer with significant morbidity, by early therapy administered when the disease is still asymptomatic," Rajkumar said.

The findings of the 2019 study, which was conducted by the Eastern Cooperative Oncology Group, in conjunction with the findings of the 2015 Spanish study, suggest a new standard of care for patients with middle- to high- risk smoldering multiple myeloma, according to investigators.


Lonial S, Jacobus SJ, Weiss M, et al. E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma. Presented at: 2019 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 8001.