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Lenalidomide Maintenance in Newly Diagnosed Patients: Myeloma XI Trial

By: Celeste L. Dixon
Posted: Monday, January 21, 2019

In patients with newly diagnosed multiple myeloma who had at least minimal response to induction therapy, lenalidomide maintenance significantly improved progression-free survival versus observation—but not overall survival. The results, from an analysis of part of the open-label, randomized, phase III Myeloma XI trial, were published in The Lancet Oncology.

Graham H. Jackson, MD, of the Northern Institute for Cancer Research, Newcastle University, United Kingdom, and colleagues noted that in this section of Myeloma XI, 1,917 adult patients with symptomatic or nonsecretory multiple myeloma were accrued between 2011 and 2017. After response to induction therapy, they were randomly assigned to lenalidomide maintenance (n = 1,137) or observation (n = 834).

After a median follow-up of 31 months, the median progression-free survival was 39 months in the treatment arm and 20 months in the observation arm (P < .0001), warranting further investigation of the drug in this setting, the authors stated. The 3-year overall survival rates for the two groups were 78.6% and 75.8%, respectively (P = .15). There were “encouraging results in subgroup analyses of patients across all cytogenetic risk groups,” wrote the investigators, including standard-risk, high-risk, and ultra-high–risk patients, although those analyses’ results “were not powered [and] should be interpreted with caution.”

Dr. Jackson’s team characterized lenalidomide’s safety profile as manageable, with no deaths in the treatment arm deemed to be drug-related. Serious adverse events were reported in 45% of the lenalidomide-arm patients versus 17% of those in the observation arm.

“The manageable safety profile of this drug and the encouraging results in subgroup analyses of patients across all cytogenetic risk groups support further investigation of maintenance lenalidomide in this setting,” the investigators concluded.

Disclosure: The study authors’ disclosure information may be found at thelancet.com.



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