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The results of a recent Phase 2 clinical trial comparing four Velcade-based combination therapies in newly diagnosed multiple myeloma patients show that a four-drug combination containing Velcade, Revlimid, cyclophosphamide, and dexamethasone led to similarly high response rates as the three-drug regimens, but resulted in a higher rate of side effects.

“We were hoping to see more activity at the same level of toxicity as the three-drug combination, but the result was similar efficacy at higher toxicity,” said Dr. Shaji Kumar of the Mayo Clinic in Rochester, Minnesota, and lead investigator of the …

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OncoPep and Dana-Farber Sign License Agreement For Myeloma Vaccine Technology – The biotechnology company OncoPep has signed a license agreement with the Dana-Farber Cancer Institute in Boston to further develop and commercialize PVX-410, a potential vaccine-based treatment for multiple myeloma. PVX-410 has been shown to stimulate an immune response against myeloma cell lines. Researchers plan to conduct a Phase 1/2a study this year of PVX-410 in patients with smoldering multiple myeloma.  OncoPep also hopes to use the PVX-410 technology to develop additional cancer vaccines. For more information, please see the OncoPep press release (pdf).

Celgene Invests $15 Million In Acetylon Pharmaceuticals – Celgene, the company that markets the myeloma treatments Revlimid (lenalidomide) and thalidomide (Thalomid), announced last week that it will invest $15 million in Acetylon Pharmaceuticals. Acetylon is developing ACY-1215, a selective HDAC inhibitor being investigated in a Phase 1/2  clinical trial with relapsed/refractory multiple myeloma patients. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat. Acetylon hopes that ACY-1215, which is more selective than other HDAC inhibitors, will be more effective and have fewer side effects. For more information, please see the Acetylon press release.

Anti-Alcoholism Drug Antabuse May Be Active Against Myeloma – In a recent preclinical study, Italian researchers demonstrated that Antabuse (disulfiram), a drug approved by the U.S. Food and Drug Administration to treat chronic alcoholism, has anti-myeloma effect. Antabuse, alone or in combination with copper, killed myeloma cell lines and cells from 22 newly diagnosed and relapsed/refractory myeloma patients. According to the Italian researchers, Antabuse was comparable to standard chemotherapy in terms of its ability to kill myeloma cells, but it did not harm healthy blood cells. For more information, please see the study in the International Journal of Cancer (abstract).

Generic Zometa Recommended For Approval In Europe – Zoledronic Acid Actavis, a generic version of Zometa (zoledronic acid) from the company Actavis, has received a positive recommendation for approval in the European Union.  The committee that provides guidance to the European Medicines Agency (EMA) made the recommendation last week.  If approved, Zoledronic Acid Actavis, like Zometa, will be available for use in the prevention of skeletal events in persons with advanced cancers involving bone, and for the treatment of tumor-involved high calcium levels. For more information, see the EMA announcement (pdf).

Cyclophosphamide-Velcade-Dexamethasone Combination Is Effective In Patients With Amyloidosis – Two research studies were published last week showing that a combination regimen used in the treatment of myeloma -- cyclophosphamide (Cytoxan) in combination with Velcade (bortezomib) and dexamethasone (Decadron), often abbreviated CyBorD or VCD -- may be effective in the treatment of amyloidosis. Amyloidosis is a blood disorder that results in the abnormal accumulation of proteins in tissues and organs throughout the body.  An estimated 10 percent to 15 percent of myeloma patients also develop symptoms associated with amyloidosis (see related Beacon news). Stem cell transplantation is a standard treatment for amyloidosis patients who are eligible. One of the studies published last week was a retrospective study that showed that 94 percent of amyloidosis patients responded to CyBorD treatment, and 18 percent of patients who were initially ineligible for a stem cell transplant became eligible following the treatment. The second study also was a retrospective analysis.  It found that 81 percent of amyloidosis patients responded to CyBorD treatment, and researchers also observed a rapid improvement in patients’ organ function.  For more information, please see the first and second studies in the journal Blood (abstracts).

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Results of a recent study show that newly diagnosed multiple myeloma patients initially treated with a combination of cyclophosphamide, Velcade, and dexamethasone have better response rates and less severe side effects than patients treated with Revlimid-dexamethasone or cyclophosphamide-Revlimid-dexamethasone.

The survival outcomes for the patients treated with cyclophosphamide, Velcade, and dexamethasone also are promising.

However, the difference in survival rates between the three treatment regimens is not statistically significant.

This is partly because "the numbers [of patients in the study] were too small to show differences in survival,” explained Dr. Craig Reeder of the …

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The results of a recent Phase 2 trial show that the addition of cyclophosphamide to Revlimid and low-dose dexamethasone may result in better responses for previously untreated myeloma patients.

“This [study] provides the efficacy of another regimen for use in patients with myeloma,” said the study’s lead author Dr. Shaji Kumar of the Mayo Clinic in Rochester, Minnesota. “It is a fairly safe combination and is quite efficacious,” he stated in an e-mail to The Myeloma Beacon.

According to the study authors, the combination of Revlimid (lenalidomide), cyclophosphamide (Cytoxan) and …

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A Phase 2 trial of Hycamtin, cyclophosphamide, and melphalan showed that the drug combination is a safe and effective treatment regimen for patients with relapsed and refractory multiple myeloma or patients in first remission. The combination, followed by stem cell transplantation, resulted in an overall response rate of 85 percent and a four-year overall survival rate of 66 percent, making this drug combination comparable in efficacy to treatment with melphalan alone.

High-dose melphalan (Alkeran) is the standard conditioning treatment for multiple myeloma patients who will receive an autologous stem cell transplant. …