Multiple myeloma "tends to relapse and, in the past, there have not been many options for therapy other than stem cell transplant, which can be very rigorous and high risk for patients," Dillon said. "This is a disease that is very common, more common in older adults than in younger people, where the risk of transplant is higher than it even is in younger population."
Thalidomide had shown benefits against multiple myeloma, but side effects of fatigue, neuropathy, constipation and blood clots were severe.
The first study took place in Canada and in the United States and involved 353 patients who had undergone at least one previous therapy for their disease. Participants were randomized to receive either 25 milligrams of Revlimid or a placebo for the first three weeks. Both groups received dexamethasone on days 1 to 4, 9 to 12 and 17 to 20 of the first four cycles.
Sixty-one percent of participants receiving the combination therapy had complete, near complete or partial responses, versus only 19.9 percent in the placebo group. In the combination group, 14.1 percent had complete responses, compared with 0.6 percent in the placebo group.
Median time to progression of the disease was also longer in the combination group: 11.1 months versus 4.7 months for those on placebo.
Median survival was 29.6 months in the Revlimid group and 20.2 months in the placebo group.
High-level side effects were seen in 85.3 percent of the Revlimid group and 73.1 percent of the placebo group. More people in the Revlimid group had neutropenia (a lowering of white blood cells) and blood clots.
"We showed that lenalidomide minimized neuropathy but blood clots still remained an issue, so people still need to have some form of anti-thrombotic medicine with this drug," Weber said.
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