Drug for Multiple Myeloma Demonstrated to Significantly Extend Disease-Free Survival
Initial results from a large, randomized clinical trial for people with multiple myeloma showed that people 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 those who received a placebo.
The clinical trial, for people with multiple myeloma ages 18 to 70, was sponsored by the National Cancer Institute, and conducted by a network of researchers led by the Cancer and Leukemia Group B in collaboration with the Eastern Cooperative Oncology Group and the Blood and Marrow Transplant Clinical Trials Network.
The independent data and safety monitoring committee overseeing the trial (known as CALGB-100104) found that the study demonstrated a longer time before the cancer progressed following autologous blood stem cell transplantation for those people on the study drug than those on placebo; therefore, the trial was stopped early.
Among the participants who received placebo, half had their myeloma progress (worsen) within an estimated 778 days. In contrast, for those taking lenalidomide, a median time to progression cannot be defined because fewer than half had worsening of their myeloma. This represents a 58 percent 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 randomized Phase III trial (the final and most comprehensive aspect of a three-phase clinical trials process) 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.
“This study answers the important question for multiple myeloma patients regarding maintenance lenalidomide therapy starting at 100 days following transplant,” says Philip L. McCarthy Jr., MD, associate professor of Medicine at Roswell Park Cancer Institute and principal investigator of this study. “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.”
Lenalidomide, a derivative of thalidomide, was approved by the U.S. Food and Drug Administration in 2006 to be used in combination with dexamethasone, a steroid, for the treatment of multiple myeloma in people who received at least one prior therapy for their disease.
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