The findings were the result of an international, multicenter, randomized, double-blind, placebo-controlled clinical trial. They come after years of study by Dr. Rajkumar, a hematologist/oncologist, and his colleagues, into the most effective treatments for multiple myeloma.
"We are happy to be able to report such positive results for this still incurable cancer," said Dr. Rajkumar. "Not only have we consistently shown that Thal/Dex reduces the amount of cancer cells in the bone marrow, but now we can state that primary therapy with this combination produces superior long-term results compared to dexamethasone alone."
An earlier Eastern Cooperative Oncology Group randomized study (www.jco.org/cgi/content/full/24/3/431) led by Dr. Rajkumar showed that a significantly larger proportion of patients with newly diagnosed multiple myeloma responded to the Thal/Dex combination compared to dexamethasone alone (63 percent versus 41 percent respectively). That study led to the Food and Drug Administration (FDA) granting accelerated approval two weeks ago for thalidomide use in treating newly diagnosed multiple myeloma.
In this most recent study, Dr. Rajkumar's team found that the average time to disease progression (increase in cancerous cells) was approximately eight months for patients taking dexamethasone alone, while patients on the Thal/Dex regimen had an average progression time exceeding 17 months. "The average progression time will likely increase,
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5-Jun-2006