National Institutes of Health (NIH) has presented data from the clinical trial on Revlimid. Initial results from a large, randomised clinical trial for patients with multiple myeloma, showed that patients who received the oral drug Lenalidomide (Revlimid, also known as CC-5013) following a blood stem cell transplant had their cancer kept in check longer than patients who received a placebo.
The study involves a total of 460 patients who had adequate organ function and no evidence of progressive disease, were randomized between 90 and 100 days after transplant to receive lenalidomide or placebo. Patients began lenalidomide or placebo between day 100 to 110 and continued until they had evidence of progressive disease.
Among the patients who received placebo, half had their myeloma progress within an estimated 778 days. In contrast, for those patients taking lenalidomide, a median time to progression cannot be defined because fewer than half the patients had worsening of their myeloma. This represents a 58% reduction in the risk of disease progression for the group taking lenalidomide. This difference in time to progression was highly statistically significant.
This is the first randomised phase 3 trial to demonstrate a clinical benefit of Lenalidomide following transplant for multiple myeloma. However, the trial has not yet shown evidence of an overall survival benefit.
Philip McCarthy, associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study, said: “This study answers the important question for multiple myeloma patients regarding maintenance lenalidomide therapy starting at 100 days following transplant.
“We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression. This is an exciting advance in the field of multiple myeloma therapy and occurred due to the willingness of multiple myeloma patients to participate in this study and to the cooperation of the many physicians and study groups involved.”