|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Oncology Nurse Advisor‘s conference coverage.
Lenalidomide reduced the risk of disease progression among patients with intermediate- or high-risk smoldering multiple myeloma, according to data from the phase 2/3 E3A06 clinical trial (ClinicalTrials.gov identifier: NCT01169337). The trial results will be presented at the upcoming 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The trial had a phase 2/3 design and enrolled patients with intermediate- or high-risk smoldering multiple myeloma. For the phase 2 portion, a single group of 44 patients received lenalidomide.
Once the safety of lenalidomide was demonstrated in the phase 2 portion, a phase 3 study was conducted, and patients were randomly assigned to either the lenalidomide arm (90 patients) or observation arm (92 patients). Patients enrolled in the intervention arm received lenalidomide 25 mg orally each day for 21 days of the first 28 days of a treatment cycle.
In the phase 2 portion of the trial, 87% of participants were still alive without disease progression at 3 years of follow-up. In the randomized phase 3 portion, 91% of patients remained alive without disease progression in the lenalidomide arm compared with 66% in the observation arm at 3 years of follow-up.
Both hematologic and nonhematologic treatment-related adverse events were seen among patients who received lenalidomide, and discontinuation rates were high. In the phase 2 portion, 34.1% of patients had grade 3 events and 11.4% had grade 4 events; 80% of patients discontinued treatment with lenalidomide. In the phase 3 portion, 35.2% of patients on the lenalidomide arm had grade 3 events and 5.7% had grade 4 events; 51% of patients in phase 3 discontinued treatment with lenalidomide.
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- 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 (ASCO) Annual Meeting; Chicago, IL; May 31-June 4, 2019. Abstract 8001.
This article originally appeared on Cancer Therapy Advisor