Thalidomide delays disease progression in newly diagnosed multiple myeloma, study shows

07-06-2006

Celgene Corporation (CELG) announced that updated clinical data from an ongoing multicentered, randomized, placebo-controlled phase 3 study (MM-003) of oral combination therapy thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma were reported at the 42nd American Society of Clinical Oncology (ASCO) Meeting in Atlanta, Georgia.

Thalidomide is currently indicated in the United States for use as a treatment in combination with dexamethasone for newly diagnosed multiple myeloma. The effectiveness of thalomid is based upon response rates. There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.

The study reported that the combination of thalidomide (Thalomid) plus dexamethasone led to a statistically significant improvement (p=.0001) in median time to disease progression, the primary endpoint of this phase 3 trial, in patients receiving thalidomide plus dexamethasone compared to patients receiving dexamethasone alone. The median overall survival and median time to disease progression have not been reached in the thalidomide plus dexamethasone arm of the study.

The data were presented at an oral session by Vincent Rajkumar, MD, a Mayo Clinic hematologist and oncologist.

The thalidomide phase 3 special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 470 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multicentered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization 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.

If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug.

This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2006, Pain & Central Nervous System Week via NewsRx.com.