Lenalidomide therapy after autologous stem-cell transplantation (ASCT) significantly prolongs time to progression in patients with multiple myeloma, according to a study published in The Lancet Haematology.
A previous analysis of the phase 3 CALGB (Alliance) 100104 study (ClinicalTrials.gov Identifier: NCT00114101) at median follow-up of 34 months revealed that lenalidomide prolonged time to progression, overall survival, but increased the risk of second primary malignancies.
Researchers enrolled 460 patients and randomly assigned them to receive lenalidomide or placebo in this double blind study. The study was unblinded after 3 interim analyses at a median follow-up of 18 months, at which point 86 of 128 patients receiving placebo without progressive disease crossed over to the lenalidomide arm.
The median follow-up for this updated survival analysis was 91 months. The median time to progression in the lenalidomide arm was 57.3 months (95% CI, 44.2-73.3) vs 28.9 months (95% CI, 23.0-36.3) for the placebo arm (hazard ratio [HR], 0.57; 95% CI, 0.46-0.71; P <.0001).
In the lenalidomide group, 18 (8%) hematologic and 14 (6%) solid tumor second primary malignancies occurred after randomization and prior to disease progression vs 3 (1%) hematologic and 9 (4%) solid tumor second primary malignances in the placebo group. Three hematologic and 5 solid tumor second primary malignancies in the placebo arm were in the crossover subgroup.
The most frequently reported grade 3 to 4 adverse events (AE) were neutropenia (50% of patients in the lenalidomide arm vs 18% in placebo arm) and thrombocytopenia (15% in the lenalidomide arm vs 5% in placebo arm).
The authors conclude saying, “Despite an increase in hematological adverse events and second primary malignancies, lenalidomide maintenance therapy after ASCT significantly improved time to progression and could be considered a standard of care.”
1. Holstein SA, Jung SH, Richardson PG, et al. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. [published online August 18, 2017]. Lancet Haematol. doi: 10.1016/S2352-3026(17)30140-0