Amy Pierre, MSN, ANP-BC , of the Memorial Sloan Kettering Cancer Center, and Nancy M. Nix, PharmD, BCPS, BCOP of St. Joseph’s/Candler Health System offer an advanced practitioner perspective on trials assessing the efficacy and safety of novel agents in smoldering and relapsed/refractory multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia.

The ENDURANCE trial consisted of two parts. Part 1 evaluated induction therapy with VRd vs KRd in newly diagnosed patients with multiple myeloma. Part 2 randomly assigned patients from both arms again to two different duration of maintenance lenalidomide (every 4 weeks for 2 years or every 4 weeks until disease progression). During his presentation at ASCO20, Dr. Kumar reported results of part 1.To be eligible for enrollment in ENDURANCE, patients had to have newly diagnosed symptomatic multiple myeloma with no intent for immediate upfront ASCT. Patients with high-risk features were excluded, with the exception of t(4;14), which some consider to be a high-risk feature. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1; they also had to have adequate hematologic parameters and no organ failure. Peripheral neuropathy, heart failure, and myocardial infarction were exclusion criteria.At baseline, both arms were well balanced for disease characteristics. Nearly one-third of patients were 70 years of age or older, and almost 12% were black. Nearly 10% had t(4;14). "The percentage of black patients [who are at higher risk] was much higher than in typical phase III trials," Dr. Kumar noted.Patients were randomly assigned 1:1, and 1,053 of them started treatment. Induction therapy with VRd was given every 3 weeks, for a total of 12 cycles, and KRd was given every 4 weeks, for a total of 9 cycles. Induction therapy was completed by 43% of those assigned to VRd vs 61.6% of the KRd group.Progression-free survival was analyzed at the second interim analysis, when 79% of planned events had occurred from the time of induction randomization. At that time, the results were released for futility.