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Paul Richardson, MD
A new three-drug combination has shown in a phase I/II 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 II
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.
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
Fifteen of the 35 newly diagnosed patients in the open-label phase II
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.
Richardson says it was "particularly exciting" to observe that 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," Richardson
says. The main adverse effect was peripheral neuropathy (numbness or
pain in the extremities), which typically cleared up after dosages were
lowered and the treatment was completed. "Our conclusion is that this
is a highly effective regimen for newly diagnosed multiple myeloma
patients," says Richardson. "The combination has now gone into large
phase 3 clinical trials, and we think it has the potential to be a new
standard of treatment in multiple myeloma."
Senior author of the report is Kenneth Anderson, MD of Dana-Farber.
Other authors are from Emory University, the University of Michigan, St.
Vincent's Comprehensive Cancer Center in New York City, Massachusetts
General Hospital, Beth Israel Deaconess Medical Center in Boston, and
Celgene Corp. of Summit, NJ.