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Weekly Velcade Maintenance Therapy After Velcade-Based Initial Therapy Improves Response Rates In Elderly, Newly Diagnosed Myeloma Patients (ASH 2010)

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Published: Dec 22, 2010 2:50 pm

A recent study showed that Velcade maintenance therapy modestly increased and deepened responses in elderly, newly diagnosed multiple myeloma patients after Velcade-based induction therapy. Maintenance therapy also caused small increases in the frequency of side effects.

Dr. Ruben Niesvizky of Weill Cornell Medical College in New York presented the study results at the American Society of Hematology (ASH) annual meeting in Orlando at the beginning of the month.

Prior to the recent development of novel therapeutic agents, the treatment for multiple myeloma was limited primarily to conventional chemotherapy and stem cell transplantation. However, recent research has demonstrated that novel agents, such as Velcade (bortezomib), Revlimid (lenalidomide), and thalidomide (Thalomid), may be used as frontline treatment for patients newly diagnosed with multiple myeloma.

Research has indicated that Velcade is highly active both as a single agent and in combination with other drugs. Dr. Niesvizky and his colleagues sought to determine if maintenance therapy with weekly Velcade could further improve the outcomes of three Velcade-based induction regimens.

Dr. Niesvizky and his colleagues randomly assigned 502 elderly, newly diagnosed myeloma patients to one of three induction treatment arms: Velcade, thalidomide, and dexamethasone (Decadron) (VTD); Velcade and dexamethasone (VD); and Velcade, melphalan (Alkeran), and prednisone (VMP). Patients received eight 21-day cycles of treatment, followed by five 35-day cycles of maintenance with weekly Velcade.

The results presented at the ASH meeting were based on the first 300 patients who completed the eight induction cycles as well as the five maintenance cycles.

As previous studies have shown, the Velcade-based induction therapies were effective, with VTD eliciting the highest response rate, followed by VMP, and then VD.

Seventy-eight percent of patients in the VTD treatment group, 71 percent in the VMP treatment group, and 68 percent in the VD treatment group responded to the induction treatment, with 36 percent (VTD), 31 percent (VMP), and 24 percent (VD)  achieving a complete or near-complete response.

Maintenance therapy caused small increases in the overall response rates for all three treatments.  Overall response rates were 79 percent for VTD, 73 percent for VMP, and 71 percent for VD when followed by maintenance therapy with Velcade.

The share of patients who achieved a complete response or near-complete response after maintenance increased to 38 percent for VTD, 34 percent for VMP, and 31 percent for VD, with Velcade maintenance having the largest impact on the complete response rate of patients receiving VD induction.

The median progression-free survival (after a median follow-up of 13.4 months) had a similar trend: 18.4 months for VTD, 17.3 months for VMP, and 13.8 months for VD.  All patients received maintenance therapy, so no direct conclusions were made about the effect of Velcade maintenance on progression-free survival.

Although induction therapy with VTD appeared to be most effective, it was also associated with the highest rate of side effects.  After the eight induction cycles, the frequency of severe or life-threatening side effects was 84 percent in the VTD arm, 79 percent in the VMP arm, and 70 percent in the VD arm.

After maintenance therapy, the frequency of severe side effects increased to 86 percent in the VTD arm, 80 percent in the VMP arm, and 74 percent in the VD arm.

Additionally, the VTD arm had the highest percent of patients who discontinued treatment due to side effects (41 percent for VTD versus 35 percent for VMP and 29 percent for VD).

The most common severe or life-threatening side effects were peripheral neuropathy (pain and tingling in the arms and legs), fatigue, low white blood cell counts, and diarrhea.

Dr. Niesvizky and his colleagues observed the highest frequency of peripheral neuropathy in the VTD arm after induction (59 percent for VTD versus 43 percent for VMP and 45 percent for VD). However, maintenance therapy did not cause a significant increase in the frequency of peripheral neuropathy (61 percent for VTD versus 45 percent for VMP and 49 percent for VD).

For more information, please refer to abstract 619 on the American Society of Hematology Meeting annual meeting website or the Millennium press release.

Photo by Opabinia Regalis on Wikipedia – some rights reserved.
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3 Comments »

  • Lori Puente said:

    What seems to be missing from these findings, as reported, is whether the patients were further randomized into low risk and high risk myeloma groups. Or am I missing the data in the reports. If anyone knows I would be interested.

  • Suzanne Gay said:

    Also, define “elderly.”

  • Jessica Langholtz (author) said:

    Hi Suzanne,

    The study’s abstract does not include a minimum age for patients included in the study. However, they list the median patient age for each treatment arm: 73.5 years for VD, 73.0 years for VTD, and 72.0 years for VMP.

    Hope this helps clarify your question.
    Jessica