Lenalidomide after stem-cell transplantation for multiple myeloma Full Text
New England Journal of Medicine, 05/16/2012
McCarthy PH et al. – Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma.Methods
- Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression.
- The starting dose of lenalidomide was 10 mg per day (range, 5 to 15).
- The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group.
- At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide.
- At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died.
- The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001).
- A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03).
- More grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons).
- Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%).