Multiple myeloma clinical trial closes early

ANN ARBOR, MI – The Southwest Oncology Group has permanently closed enrollment in a federally funded clinical trial that compares a standard drug therapy, dexamethasone, with a combined therapy of the same drug plus the drug lenalidomide (marketed as Revlimid ® by Celgene Corporation) for people newly diagnosed with multiple myeloma.

The Southwest Oncology Group (SWOG), the largest of several National Cancer Institute-sponsored networks that conduct clinical trials, announced that it recommends that current participants in the SWOG study, S0232, be given the choice of switching to lenalidomide with dexamethasone if they are currently taking dexamethasone alone. SWOG is also recommending using a lower dose of dexamethasone based on preliminary results of an Eastern Cooperative Oncology Group (ECOG) study which showed, in preliminary results, lenalidomide is highly effective when combined with either high doses of dexamethasone (as used in S0232) or lower doses. The ECOG study also showed in that preliminary analysis that low-dose dexamethasone plus lenalidomide may result in better one-year survival rates and fewer cases of side effects compared to high-dose dexamethasone plus lenalidomide in newly diagnosed multiple myeloma patients.

The Southwest Oncology Group’s data and safety monitoring committee based its recommendation to permanently close enrollment on the preliminary results from the ECOG clinical trial which were announced in early April. Furthermore, a number of clinical trials have suggested that dexamethasone in combination with thalidomide, a drug very similar to lenalidomide, is superior to dexamethasone alone in terms of response rates and progression free survival. The Southwest Oncology Group had temporarily suspended enrollment in its trial, S0232, on April 2 following the ECOG announcement.

The SWOG data have not been fully analyzed, but there is no indication of any unanticipated adverse outcomes in the SWOG trial, says Jeffrey Zonder, M.D., the trial’s principal investigator and a myeloma specialist at the Karmanos Cancer Institute in Detroit, Mich. Data analysis is ongoing and results will be presented and released in the usual fashion.

In October, 2004, the double-blinded SWOG Phase III trial, S0232, set out to compare progression-free survival in 500 participants given the drug lenalidomide plus dexamethasone for the disease vs. those receiving dexamethasone alone. To date, 198 participants were enrolled.

The ECOG study, E4A03, set out to test the same combination, dexamethasone and lenalidomide, but with two different doses of dexamethasone in 445 people newly diagnosed with multiple myeloma. ECOG closed its study in April, based on its preliminary findings that participants who received a low dose of dexamethasone plus lenalidomide had superior results in terms of one-year survival rate and toxicity. ECOG informed all its participating investigators to switch subjects in the group receiving the standard dose of dexamethasone plus lenalidomide to low-dose dexamethasone and lenalidomide.

Both SWOG and ECOG, like other groups the NCI sponsors, are networks of medical centers and clinics around the country that conduct clinical trials of prospective cancer treatments using National Institutes of Health grants and other funding sources.

Multiple myeloma is a cancer affecting plasma cells found in blood and bone marrow. An estimated 19,900 people will be diagnosed with the disease this year. An estimated 10,790 people will die from it.

Celgene, Inc., provides lenalidomide for the SWOG study and handles distribution of the drug to study participants through an agreement with SWOG.

The Southwest Oncology Group is the largest cancer clinical trials cooperative group in the United States. Funded by research grants from the National Cancer Institute, part of the National Institutes of Health, the group conducts clinical trials to prevent and treat cancer in adults, and to improve the quality of life for cancer survivors. The group’s network of more than 5,000 physician-researchers practice at nearly 550 institutions, including 16 National Cancer Institute-designated cancer centers. Headquartered in Ann Arbor, Mich. (734-998-7130), the group has an operations office in San Antonio, Tex. and a statistical center in Seattle, Wash.

Written by: Anne Rueter