Preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma, has shown that the use of a low dose of the steroid Dexamethasone ( Decadron ), in combination with Lenalidomide ( Revlimid ) is associated with improved survival when compared to a treatment regimen with Lenalidomide and a higher, standard dose of Dexamethasone.
The clinical trial was conducted by a network of researchers led by the Eastern Cooperative Oncology Group ( ECOG ).
The data monitoring committee overseeing the trial ( known as E4A03 ) recommended that the survival results from a recent interim analysis be made public because of early differences being seen in overall survival rates.
Researchers found that patients in the study who received low-dose Dexamethasone and Lenalidomide had a one-year survival of 96 percent compared to 86 percent for patients treated with the standard-dose of Dexamethasone and Lenalidomide. In addition, there were fewer side effects associated with the low-dose Dexamethasone and Lenalidomide.
A total of 445 patients with newly diagnosed multiple myeloma, who had not previously received chemotherapy, were enrolled in this study between 2004 and 2006. Patients were randomized to one of two treatment arms. One patient group received Lenalidomide and Dexamethasone given at standard doses. The second group received Lenalidomide and low-dose Dexamethasone.
The primary objective was to determine if the low-dose arm would have similar response rates and lower toxicity than the standard-dose arm.
Lenalidomide, a derivative of Thalidomide, was approved by FDA ( Food and Drug Administration ) in 2006 to be used in combination with Dexamethasone for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease.
Dexamethasone is a steroid that acts as an anti-inflammatory and as an immunosuppressant.
In 2007, an estimated 19,900 people in the United States will be diagnosed with multiple myeloma and an estimated 10,790 people will die of the disease.
Source: National Institutes of Health ( NIH ), 2007