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ASH 2008 – Clinical Trial Update for Velcade-Thalidomide-Dexamethasone With Autologous Stem Cell Transplantation In Newly Diagnosed Myeloma Patients

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Published: Dec 11, 2008 9:29 am

At the American Society of Hematology (ASH) meeting this Monday, researchers from Italy reported the positive results of a Phase 2 clinical trial combining Velcade (bortezomib) with thalidomide (Thalomid) and dexamethasone (VTD) for the treatment of newly diagnosed multiple myeloma patients. The drug combination was used as an induction regimen to reduce the tumor in preparation for melphalan-based autologous stem cell transplantation.

Chemotherapy combined with autologous stem cell transplantation – stem cells collected and returned to the same individual - is a typical treatment option in newly diagnosed myeloma patients. Stem cell transplantation replaces the normal stem cells destroyed during the chemotherapy treatment, leading to higher response rates and longer survival. Patients are treated with several cycles of a high-dose induction regimen, followed by treatment with the standard chemotherapy agent melphalan and stem cell transplantation.

The results for the VTD induction regimen were directly compared to the commonly used thalidomide-dexamethasone (TD) combination for newly diagnosed patients. Researchers found that patients treated with three cycles of VTD prior to stem cell transplantation had higher partial rates of response or better than those treated with TD - 92 percent versus 78.5 percent; including a complete response of 21 percent versus 6 percent, a near complete response of 12 percent versus 6 percent, and a very good partial response rate or better of 61 percent versus 30 percent.

Importantly, no patients treated with VTD had disease progression after the induction regimen compared to 4.5 percent of patients treated with TD. Serious adverse effects were similar for the two treatments while VTD treated patients did show a higher frequency of peripheral neuropathy – pain and numbness in hands and feet. However, discontinuation of therapy due to treatment-related adverse side effects was similar for both groups.

After the stem cell transplantation, VTD patients achieved a complete response of 41 percent compared to 20 percent for TD patients, a near complete response of 13 percent versus 9 percent, and a very good partial response or better of 75 percent versus 53 percent.

Patients were also evaluated for a possible second stem cell transplant followed by consolidation therapy with either VTD or TD. Consolidation is used to further reduce the number of cancer cells and achieve even higher response rates. Patients who met the requirements for the second transplant were similar between the VTD and TD treated groups. However, results regarding either the second transplantation or subsequent consolidation therapy have not yet been reported.

An update at the ASH meeting showed that the two-year prolonged progression-free survival for VTD treated patients was 90 percent compared to 80 percent of TD treated patients. The 20-month overall survival rate, however, was 93 percent for both treatment groups.

For more information, see abstract 158 at the ASH meeting website and the associated press release.

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2 Comments »

  • m.Richardson said:

    Geachte Hr?Mw. Ik ben een patient die velcade kuur heb gehad,en heb nu last van neuropathy,van mijn dokter heb ik vit b6-b12 gekregen.
    Mijn vraag is wat kan ik nog meer erbij gebruiken ,om dat ik nog heelveel last heb,van pijnlijlke armen en benen.
    mijn dank.

    [Rough English translation: "Dear Sir/Madam. I am a patient who has had a course of Velcade, and I now suffer from neuropathy. From my doctor I have received vitamin B6 and B12. My question is: What can I do to address the pain that I still have in my arms and legs? Thank you." - Editors.]

  • Emily Cole said:

    Thank you for your comment, m.Richardson. We must first advise you to speak to your physician again or obtain a referral to another specialist. Side effects can often worsen and lead to serious complications if left untreated.

    Also, you may find some information about neuropathy related to Velcade treatment at the MMRF:
    http://www.multiplemyeloma.org/treatments/3.05.php

    "Side effects can often be managed with other medications, increasing the amount of fluid you drink, reducing the dose of Velcade, or stopping Velcade treatment temporarily until symptoms resolve."

    Also, you may want to search for patient message boards related to Velcade induced neuropathy, here is one such link:
    http://www.cancercompass.com/message-board/message/all,27322,0.htm

    I hope this information is useful for you. Good luck with your treatment!