An external Independent Data Monitoring Committee (IDMC) analysis of the multi-centred, randomised, placebo-controlled phase III study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma, conducted by Celegene Corporation, met the pre-specified p<0.0015 value for stopping the trial.

The IDMC found time to disease progression the primary endpoint of this phase III trial of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving Thalomid plus dexamethasone compared to patients receiving dexamethasone alone.

Treatment assignments for patients currently on the trials will be unblinded and those currently not on Thalomid will have the opportunity to add Thalomid to their dexamethasone regimen, states a Celegene release.

The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomised to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomised to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centred clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomisation to the first documentation of progressive disease based on Blade myeloma response criteria.

Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.

Thalomid (thalidomide), manufactured by Celgene Corporation, received US Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide currently has a pending regulatory application (sNDA) under review by the FDA. Thalidomide is not presently indicated or approved by the FDA for use in any related cancer.

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow.