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Perifosine Combination Therapy Is Promising For Relapsed And Refractory Multiple Myeloma (ASH 2009)

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Published: Dec 17, 2009 10:47 am

Results from recent Phase 1/2 clinical trials show that a perifosine, Velcade (bortezomib) and dexamethasone (Decadron) combination treatment is safe and effective for relapsed and refractory multiple myeloma. Perifosine is an alkyl-phosphocholine compound that controls cell division, cell growth and cell death, and is currently investigated for the treatment of multiple myeloma. Researchers presented their findings on December 5 at the American Society of Hematology’s 51st Annual Meeting.

“Great meeting—lots of exciting new developments for multiple myeloma,” wrote Dr. Paul Richardson, lead researcher in the study, in an e-mail to the Myeloma Beacon. He added that his trial results were “well received—especially the durability seen of benefit.”

The trial looked at 84 people with relapsed or refractory multiple myeloma who had undergone a median of five full courses of previous treatment, or about 30 months of chemotherapy.

All participants had been previously treated with Velcade, and many had also been treated with dexamethasone, Revlimid (lenalidomide), thalidomide (Thalomid) or stem cell transplants. In the trial, they were treated with perifosine and Velcade. Those whose multiple  worsened also took dexamethasone.

Seventy-three participants finished at least two cycles of the new perifosine and Velcade treatment. Thirty of those patients (41 percent) responded to the treatment, with 16 (22 percent) reaching partial response or better. The median time it took for the participants’ cancer to worsen was 6.4 months. Median overall survival time for all patients was 25 months.

To determine the side effects of the new treatment, researchers looked at all 84 participants. At least 10 percent experienced nausea, mild or moderate diarrhea, vomiting, fatigue or anorexia. These are milder side effects that the researchers managed by reducing the participants’ treatment dosages or with supportive care. At least five percent of the participants experienced severe side effects including low amounts of platelets in their blood, which can lead to abnormal bleeding; low amounts of infection-fighting cells called neutrophils; anemia; salt imbalances, which cause swelling in the brain; or severe diarrhea. Although none of the participants died from the new treatment, six people dropped out of the trial because of the severity of their side effects.

The new treatment is generally safe and effective, researchers concluded. “[It is] especially good to see [positive responses] in patients in whom prior Revlimid and Velcade has failed them,” wrote Dr. Richardson.

They have received a Special Protocol Assessment from the Food and Drug Administration (FDA), according to a press release by Keryx Biopharmaceuticals, the manufacturer of perifosine. This means that the FDA and Keryx Biopharmaceuticals have reached an agreement about the design of the Phase 3 trial. They plan to start that trial by the end of the year.

For more information, please see abstract 1869 on the ASH meeting Web site or the Keryx Biopharmaceuticals press release.

Photo by Tom Varco on Wikipedia – some rights reserved.
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