A large cooperative-group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but increasingly common cancer of the blood and marrow. Updated results of the ongoing study, which is led by Philip McCarthy, MD, and Sarah Holstein, MD, PhD, of Roswell Park Cancer Institute (RPCI), will be highlighted during a poster discussion session at the American Society of Clinical Oncology (ASCO) 51st Annual Meeting in Chicago.
This randomized phase III study compares maintenance, or ongoing, therapy with lenalidomide (Revlimid) following autologous stem-cell transplant in patients newly diagnosed with multiple myeloma. The trial's 461 participants, all under 70 years old, showed evidence of stable or controlled disease at 100 days post-transplant before they were randomly assigned to either the treatment arm or the placebo arm. While incidence of second primary malignancies was elevated among patients who received lenalidomide, the researchers found a marked benefit for those receiving maintenance doses of the drug.
"The results demonstrate that maintenance therapy with lenalidomide significantly improves both time to disease progression and overall survival, and that these benefits apply regardless of whether patients were in complete response at randomization or whether they had previously received thalidomide or lenalidomide as induction therapy," says Dr. Holstein, Assistant Professor of Oncology in Roswell Park's Department of Medicine, the study's first and presenting author.
Estimated median time to progression was nearly doubled for those receiving treatment, from 27 months for the placebo group to 53 months for those receiving lenalidomide. After 65 months median follow-up, the median overall survival has not yet been reached for those receiving lenalidomide and is 76 months for the placebo group. Among those receiving treatment, 25 secondary primary malignancies were observed, compared to 10 in the placebo arm. The study was unblinded at 18 months median follow-up, and 86 patients from the placebo arm who showed no evidence of disease progression chose to cross over to the treatment group.
"Our findings provide compelling evidence that this treatment approach represents advancement in our ability to control this disease and generate better outcomes for patients with multiple myeloma," notes the study's senior author, Dr. McCarthy, who is Professor of Oncology and Director of the Blood & Marrow Transplant Program at Roswell Park.
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