The Southwest Oncology Group has permanently closed enrollment in a trial comparing a standard drug therapy, dexamethasone, with a combined therapy of the same drug plus the drug lenalidomide (Revlimid) for people newly diagnosed with multiple myeloma.
The Southwest Oncology Group (SWOG) 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.