Dec. 10, 2002 PHILADELPHIA -- A drug similar to thalidomide has been found to be promising with fewer side effects for treating patients with recurrent multiple myeloma, an incurable form of bone marrow cancer, according to early data from a clinical study led by Dana-Farber Cancer Institute researchers.
Paul Richardson, MD, Kenneth Anderson, MD, both of Dana-Farber, and their co-authors will present preliminary safety and effectiveness data from a large multi-center Phase II study of CC-5013 at the annual meeting of the American Society of Hematologists in Philadelphia (Dec. 9, 10:45 a.m., Room 103). Celgene Corporation manufactures CC-5013, which is also known as Revimid TM.
The drug, an analog of thalidomide, was developed to be more potent than thalidomide, while reducing some of thalidomide's dose limiting side effects. Laboratory studies led by Teru Hideshima, MD, at Dana-Farber have shown that CC-5013 not only kills myeloma cells by triggering their innate self-destruct mechanism but also inhibits the myeloma cells ability to localize and grow in the bone marrow. Moreover, it appears to have anti-angiogenic effects and stimulates the immune system to attack myeloma.
"We are encouraged by the responses seen so far, and the relative tolerability of this convenient orally active agent is a real plus for patients," says Richardson.
A Phase I study led by the same Dana-Farber investigators determined a maximum tolerated dose of the drug. The new study, which began earlier this year, compared two therapeutic regimens: one in which patients took 15 mg. of the drug twice daily for three weeks followed by a week of rest, and one in which patients followed the same schedule but with 30 mg. as a once daily dose. Dexamethasone could be added in patients in whom CC-5013 alone was not proving beneficial as laboratory studies have suggested that the two agents combined have at least additive activity in myeloma.
Preliminary results from the trial show that there is significant anti-myeloma activity with measurable responses in about 50 percent of evaluable patients treated to date. The drug has been well tolerated, with evidence that the daily dosing regimen has fewer side effects than the twice daily schedule, but equal activity.
Dana-Farber Cancer Institute (http://www.danafarber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.
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