A new three-drug combination has shown in a phase 1/2 clinical trial that it is a "highly effective regimen" in the treatment of patients newly diagnosed with multiple myeloma, a cancer of white blood cells in bone marrow, say researchers from Dana-Farber Cancer Institute.
Partial responses or better were seen in all of the 66 patients treated with the drug combination in the multi-center study, with 74 percent having a "very good partial response rate" in the phase 2 population, reports Paul G. Richardson, MD, of Dana-Farber, who led the study. The rate of complete or "near complete" responses to the therapy was also encouraging at 54 percent.
Richardson will describe the results in an oral presentation at the American Society of Hematology's 51st annual meeting on Saturday, Dec. 5 (Abstract 1218, Ernest N. Morial Convention Center, Hall E, 5:30-7:30 pm CT).
The regimen, known as RVD, combined the drugs Revlimid - (lenalidomide), Velcade - (bortezomib) and dexamethasone, which previously were found to be highly effective in multiple myeloma patients who had relapsed or no longer responded to first-line therapies.
Fifteen of the 35 newly diagnosed patients in the open-label phase 2 portion of the study subsequently underwent autologous (using their own blood-forming stem cells) transplants, a standard treatment for multiple myeloma "and did very well," says Richardson.
For the entire group, after a median 19.3 months of follow up, the median time-to-progression (TTP) of the disease, progression-free survival (PFS), and overall survival (OS) had not yet been reached, according to the presentation. The estimated TTP and PFS at one year are 76 percent, and the estimated one-year overall survival is 100 percent, the results showed.
An estimated 20,580 new cases of multiple myeloma will be diagnosed in 2009, according to the American Cancer Society, and 10,580 patients will die from the disease.