(dailyRx News) Multiple myeloma is a cancer similar to leukemia, where immune system cells in the blood begin to multiply out of control.
Newer treatments have shifted from the older types of chemotherapy to newer targeted drugs that have less side effects.
A recent study showed that the combining one of these newest drugs in its class, Kyprolis (carfilzomib), with low doses of steroids was extremely effective in causing multiple myeloma, a plasma cell leukemia, to go into remission.
At a presentation during the American Society of Clinical Oncology's annual meeting, Andrzej Jakubowiak, MD/PhD, a professor at the University of Chicago showed the latest results from his drug trial, where a majority of patients with multiple myeloma showed no evidence of cancer after treatment.
"Our final results continue to demonstrate the efficacy and safety of carfilzomib when combined with lenalidomide and dexamethasone," said Dr. Jakubowiak.
"Our data support the potential for CRd as a new frontline treatment option for patients with multiple myeloma with results that are comparable to or better than those achieved with other established frontline regimens followed by high-dose chemotherapy and stem cell transplant."
The U.S. Food and Drug Administration is currently reviewing Kyprolis for the treatment of relapsed and refractory myeloma.
"Our hope is that our results will provide an effective treatment option for patients with multiple myeloma to help bring us one day closer to curing this deadly disease," added Dr. Jakubowiak.
The results were from a combined trial for phase I and II that included 53 patients recently diagnosed multiple myeloma. Patients were treated with Kyprolis, Revlimid (lenalidomide), and dexamethasone. The patients in the trial were treated until signs of remission or toxicity were detected.
Out of the 53 patients, 49 were given four 28-day treatment cycles, 67 percent showing a good response. Out of the 53 patients, 45 percent had a complete response to the treatment, with no detectable evidence of cancer at the end of the trial.
More cycles of treatment seemed to be effective, and the group of patients given eight treatment cycles had 80 percent demonstrating a nearly complete response, and 60 percent had no detectable cancer.
In terms of delaying disease progression, the drug was very effective. Progression free survival was 97 percent at 12 months, and 92 percent at 24 months after the trial began.
Side effects reported included slight nerve damage in about 10 percent of patients, immune supression and fatigue in about a third of the patients in the trial. Nerve damage was a concern in the first generation of the drug class, and carfilzomib seems to be successful in minimizing that side effect in comparison to the first generation, Velcade (Bortezomib).
Although the final phase III of the drug's testing will provide definite proof, researchers concluded that so far the results compare very favorably to current drugs on the market for multiple myeloma.
The U.S. Food and Drug Administration has announced that they will take the trial into consideration for approval starting on July 27, 2012.
According to an article by Bloomberg News, FDA advisory panel chairman Wyndham Wilson, MD/PhD, stated that the side effects were outweighed by the need of patients.
"This is an unmet need in a group that has really run out of options," Dr. Wilson stated. "There is a pretty convincing signal here that is likely, I believe, to be confirmed in confirmatory trials."
The study was also published online in the journal Blood June 4, 2012.
Researchers disclosed financial relationships with Celgene, Onyx, Merck, Millennium, Exelixis, Bristol-Myers Squibb and Ortho Biotech.