December 18, 2009

Revlimid® Delays Progression of Multiple Myeloma


Among multiple myeloma patients who have had an autologous stem cell transplant, additional treatment with Revlimid® (lenalidomide) delays cancer progression. These results were released by the National Cancer Institute.

Multiple myeloma is a cancer of plasma cells. Plasma cells are a special type of white blood cell that are part of the body’s immune system. Plasma cells normally live in the bone marrow and make proteins, called antibodies, that circulate in the blood and help fight certain types of infections. Plasma cells also play a role in the maintenance of bone, by secretion of a hormone, called osteoclast activating factor, which causes the breakdown of bone. 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. These abnormal antibodies are referred to as paraproteins or monoclonal proteins in the blood (M proteins) or urine (Bence Jones protein).

A common treatment for multiple myeloma is high-dose therapy followed by autologous stem cell transplant. High doses of chemotherapy are more effective at killing cancer cells than lower doses. However, high-dose therapy destroys many other cells in the body, including stem cells in the bone marrow that develop into mature blood cells. A stem cell transplant restores these blood stem cells. An autologous stem cell transplant makes use of the patient’s own blood stem cells, which are collected prior to high-dose therapy. Autologous stem cell transplant is often reserved until multiple myeloma recurs after initial treatment or progresses with treatment.

Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. To explore the effect of Revlimid following high-dose therapy and autologous stem cell transplant, researchers conducted a Phase III clinical trial known as CALGB-100104. The study enrolled 568 patients with multiple myeloma who had received no more than 12 months of prior therapy and no prior transplant.

All patients were treated with high-dose melphalan followed by autologous stem cell transplant. The 460 patients who had adequate organ function and no evidence of progressive disease were then assigned to receive further treatment with either Revlimid or a placebo. This additional treatment was started between 100 and 110 days after the stem cell transplant.

  • Compared with placebo, Revlimid reduced the risk of myeloma progression by 58%. This benefit was highly statistically significant, and resulted in the study being stopped early.

In a prepared statement, the lead investigator on the study noted, “We now know that prolonged maintenance therapy with [Revlimid] 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.”

In summary, the results of the study show that Revlimid delays myeloma progression among patients who have undergone an autologous stem cell transplant. The study has not yet shown improvement in overall survival, however.

Reference: National Cancer Institute. Drug for multiple myeloma demonstrated to significantly extend disease-free survival. Available at: Accessed December 18, 2009.

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