Maintenance therapy with RevlimidÒ (lenalidomide) slowed disease progression by 54% among patients with multiple myeloma who had undergone high-dose chemotherapy and autologous stem cell transplantation. Interim results of this Phase III study will be presented at the 2010 annual meeting of the American Society of Clinical Oncology.1
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
Multiple myeloma may be treated with high-dose chemotherapy followed by autologous stem cell transplantation (ASCT), a procedure in which a patient’s own stem cells are removed prior to the high-dose therapy and then re-infused after the treatment in order to rebuild the patient’s immune system. Maintenance therapy refers to long-term treatment given after patients achieve remission with initial therapy. The goal of maintenance therapy is to prolong remission.
Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. In this Phase III study, 614 patients with multiple myeloma were randomly assigned to receive maintenance therapy with Revlimid or placebo until relapse. All patients had undergone high-dose therapy, ASCT, and two months of consolidation therapy with Revlimid.
The results from this interim analysis indicate that Revlimid maintenance therapy improved three-year progression-free survival—68% of patients in the Revlimid group remained free of disease progression compared with 35% in the placebo group. This benefit was observed regardless of whether patients had achieved a complete response after ASCT. Two-year survival was similar in both groups (95%). Revlimid was well-tolerated.
The researchers concluded that Revlimid is effective as maintenance therapy for patients with multiple myeloma and that it prolongs progression-free survival after ASCT. Final data on progression-free survival and overall survival are expected in December 2010.
1 Attal M, Cristini C, Marit G, et al. Lenalidomide maintenance after transplantation for myeloma. To be presented at the 2010 annual meeting of the American Society of Clinical Oncology. June 4-8, 2010. Chicago, IL. Abstract 8018.
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