Maintenance therapy with Revlimid® (lenalidomide) reduced the risk of myeloma progression or death by 60% among patients who had undergone an autologous stem cell transplant. These updated results from a Phase III clinical trial were presented at the 52nd annual meeting of the American Society of Hematology.
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.
Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.
The current Phase III study (CALGB 100104) evaluated the risks and benefits of Revlimid maintenance therapy after ASCT for multiple myeloma. Maintenance therapy refers to long-term treatment that is given after patients achieve remission with initial therapy. The goal of maintenance therapy is to prolong remission.
The study enrolled patients under the age of 70 with Stage I-III multiple myeloma. Patients who had stable disease or better after ASCT were assigned to receive additional treatment with either Revlimid or a placebo. Treatment continued until myeloma relapse.
This study was stopped early (in December, 2009) when results showed that patients treated with Revlimid maintenance had better progression-free survival than patients treated with placebo. Researchers continue to follow the study participants, however, and presented updated results at the 2010 ASH meeting.
Patients had been followed for a median of 17.5 months since ASCT.
- Compared with patients in the placebo group, patients in the Revlimid group had a 60% lower risk of myeloma progression or death.
- Median time to myeloma progression was 42.3 months in the Revlimid group and 21.8 months in the placebo group.
- Patients in the Revlimid group were more likely than patients in the placebo group to experience low blood cell counts and infections.
These results continue to indicate that Revlimid maintenance therapy after ASCT substantially slows myeloma progression.
Reference: McCarthy PL, Owzar K, Anderson KC et al. Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous hematopoietic stem cell transplantation (AHSCT) for multiple myeloma: CALGB 100104. Presented at the 52nd annual meeting of the American Society of Hematology. Orlando, FL, December 4-7, 2010. Abstract 37.
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