(HealthDay News) — Lenalidomide significantly delays progression to symptomatic multiple myeloma in patients with smoldering multiple myeloma, according to a study published online Oct. 25 in the Journal of Clinical Oncology.
Sagar Lonial, MD, from Emory University in Atlanta, and colleagues compared the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. A total of 182 patients were randomized and followed for a median of 35 months.
The researchers found that 50 percent (95 percent confidence interval, 39 to 61 percent) of patients in the lenalidomide arm had response to therapy compared with no responses in the observation arm. Compared with observation, lenalidomide was associated with significantly longer progression-free survival (hazard ratio, 0.28; 95 percent confidence interval, 0.12 to 0.62; P = 0.002). For the lenalidomide arm, one-, two-, and three-year progression-free survival was 98, 93, and 91 percent, respectively, compared with 89, 76, and 66 percent, respectively, for the observation arm. Six deaths were reported: two and four in the lenalidomide and observation arms, respectively (hazard ratio for death, 0.46; 95 percent confidence interval, 0.08 to 2.53). Twenty-eight percent of patients on lenalidomide had grade 3 or 4 nonhematologic adverse events.
“These results, in combination with the findings in the 2015 Spanish study, support a change in the standard of care for intermediate and high-risk smoldering myeloma patients,” a coauthor said in a statement. “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.”
Several authors disclosed financial ties to the biopharmaceutical industry.