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Beacon NewsFlashes – June 26, 2012

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Published: Jun 26, 2012 10:00 am

Subcutaneous Velcade Gets Positive Opinion From European Advisory Committee – An advisory committee of the European Medicines Agency (EMA) has granted a positive opinion recommending European approval of subcutaneous Velcade (bortezomib). The committee’s decision was based on results of a Phase 3 study demonstrating that subcutaneous Velcade is as effective as intravenous Velcade but associated with fewer and less serious side effects.  Updated, longer-term results of the Phase 3 study were recently published in the journal Hematologica (abstract).  The EMA is expected to decide whether or not to approve subcutaneous Velcade within 30 to 60 days.  For information, see the press release from Janssen-Cilag, the company that markets Velcade in Europe.

Oxycontin May Reduce Peripheral Neuropathic Pain After Velcade Treatment – Results from an Italian study suggest that treatment with the pain medication Oxycontin (controlled-release oxycodone) may help control Velcade-induced peripheral neuropathic pain that is unresponsive to other pain killers. The 62 myeloma and lymphoma patients who participated in the study reported an average reduction in pain intensity from 7.6 to 1.3 (on an 11-point rating scale) after two weeks of Oxycontin treatment. The frequency of brief pain was also reduced with Oxycontin treatment. About 75 percent of the study participants found the treatment very effective or effective; 51 percent experienced slight or mild side effects. For more information, see the related journal article in Supportive Care in Cancer (abstract).

Ibrutinib (PCI-32765) Shows Activity Against Multiple Myeloma – Results from a preclinical study suggest that the investigational drug ibrutinib (PCI-32765) is active in multiple myeloma. Ibrutinib blocks activity of an enzyme called Bruton’s tyrosine kinase (Btk). Btk is present both in antibody-producing cells and in cells called osteoclasts that remove bone tissue. Ibrutinib, which is being developed by the California-based biotech company Pharmacyclics together with Johnson & Johnson, is being investigated as a potential treatment for a number of different blood cancers. Two Phase 3 clinical trials of the drug in leukemia and lymphoma patients are about to start, and a Phase 2 trial in myeloma patients is ongoing.  For more information, see the preclinical study results in the journal Blood (abstract) and the clinical trial description for the Phase 2 myeloma trial.

Blood Calcium Levels May Be An Independent Prognostic Factor In Multiple Myeloma – Results from a small Mexican study suggest that calcium levels in the blood may be an independent  predictor of overall survival in multiple myeloma patients. Blood calcium levels typically rise during multiple myeloma, as loss of bone structure releases calcium into the blood. In this study, researchers compared the levels of hemoglobin, platelets, calcium, and a wide range of enzymes and proteins in the blood of healthy individuals and multiple myeloma patients. The level of calcium in a myeloma patient's blood was the only factor that, on its own, correlated with overall survival. For more information, please see the study in Revista de investigación clínica (abstract).

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3 Comments »

  • Ben S. said:

    Hi, Beacon Staff:

    Can you elaborate how the level of calcium correlates with overall survival? I imagine higher level of calcium would have a negative impact. Can you provide any statistics? I could only read an abstract but it does not do a good job of summarizing the findings. Thanks!

    Ben

  • Myeloma Beacon Staff said:

    Hi Ben,

    Thanks for your question.

    The Mexican study focused on measuring, not explaining, what factors seemed to be the most correlated with survival in the patients included in the study. The study was not really set up in a way that would allow the researchers to explain, with a high degree of confidence, the basis for their findings.

    That said, the authors did have the following potential explanation for why their results turned out the way they did:

    "One hypothesis that may help explain these findings is that bone disease was not too advanced in patients presenting [with] normal serum calcium. These patients had a greater possibility of controlling disease progression and thus better [overall survival]. In contrast, patients with hypercalcemia are reported to present most frequently the highest tumor mass, and destructive osteolytic bone disease supported by the vicious cycle between bone destruction and myeloma expansion."

    Bear in mind that this study is based on a rather small number of patients, so the results have to be interpreted with caution.

    It is possible to get a free copy of the study, which is in English, but you do have to register first at the website of the journal publisher. That will be a bit more challenging than usual, given that the publisher's website is in Spanish.

    This link will take you to the abstract (in Spanish) at the publisher's website: http://bit.ly/Ou2tyA . Once you've registered at the site, there is a link on the abstract page that will let you download the full article.

    You can register at the site by going to this page: http://www.imbiomed.com/1/1/registro.php .

  • Ben S. said:

    Thanks, Beacon staff!