Apr. 2, 2003 ROCHESTER, Minn. -- A Mayo Clinic study is the first to show that for some patients with early stage multiple myeloma, the drug thalidomide may effectively delay the need for chemotherapy or more aggressive treatment for as much as two years.
Multiple myeloma is an incurable cancer of the bone marrow.
The final results of the nonrandomized phase II clinical trial were published today in the April issue of the journal Leukemia. Because of the promising indications, preliminary findings were released about a year ago.
Thirty-one patients with previously untreated, early stage myeloma participated in the study. About 80 percent of the patients had not progressed in their disease one year after beginning initial treatment with thalidomide, and 63 percent were progression-free at two years.
On average, a patient with early stage myeloma progresses within two years to a symptomatic stage of the disease and requires chemotherapy treatments and stem cell transplantation.
"A direct benefit to patients of delaying the inevitable progression is the ability to live a productive life longer before needing to receive the intense treatments," says Vincent Rajkumar, M.D., a Mayo Clinic hematologist and lead researcher on the study.
Dr. Rajkumar noted, "Although it is tempting to recommend thalidomide as initial therapy for early stage myeloma based on the results of this study, we caution that our study was not randomized and that thalidomide therapy is not without side effects. At this point, we do not recommend thalidomide for early stage myeloma outside an approved clinical trial until randomized studies can be conducted." Mayo Clinic anticipates beginning a randomized trial in the next few months.
Multiple myeloma strikes about 14,600 people in the United States each year, and about 10,800 patients annually die from the disease.
Although myeloma accounts for only about 10 percent of all cancer, it is among the most difficult to control. Thalidomide, which was banned 30 years ago because it was linked to birth defects, has been found in recent years to have an effect on controlling myeloma.
Patients with early stage myeloma, which includes asymptomatic, smoldering and indolent myeloma, are typically monitored without treatment until the cancer shows symptoms of active growth. Sometimes, progression from early to active stage disease does not occur for many years.
In the Mayo Clinic study, 10 patients (34 percent) had a partial response to the thalidomide treatment with at least 50 percent or greater reduction in the serum and urine monoclonal (M) protein, an indicator of the amount of the cancer. Another nine patients had at least a 25 percent reduction in serum and urine M protein. The remaining patients had stable disease.
Side effects experienced by almost all of the patients were relatively mild and included sleepiness, tingling in the hands and feet, fatigue and constipation.
The study was funded by grants from the Mayo Clinic Cancer Center and Celgene Corporation, which manufactures the drug thalidomide.
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