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.
Partial responses or better were seen in all of the 66 patients treated with the drug combination in the multi-center study, with 74% having a very good partial response rate in the phase 2 population.
The rate of complete or near complete responses to the therapy was also encouraging at 54%.
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.
For the entire group, after a median 19.3 months of follow up, the median time-to-progression of the disease, progression-free survival, and overall survival had not yet been reached.
The estimated time-to-progression and progression-free survival at one year are 76%, and the estimated one-year overall survival is 100%, the results showed.
The high response rate was not affected by the specific genetic characteristics of the patients' disease. Patients with so-called adverse cytogenetics are at higher risk for treatment failure and death, but in the current study the drug combination worked as well for them as it did in patients with more favorable cytogenetic features.
The toxic side effects of the treatment were manageable. The main adverse effect was peripheral neuropathy, which typically cleared up after dosages were lowered and the treatment was completed.
Source: Dana-Farber Cancer Institute, 2009