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Exciting data released at ASH encourages the MMRF


CURE invited Anne Quinn Young, vice president of communications of the Multiple Myeloma Research Foundation, to offer her thoughts on the 2010 annual meeting of the American Society of Hematology and its impact on myeloma. This year's American Society of Hematology annual meeting featured exciting new data related to optimizing currently available therapies, as well as incorporating next-generation treatments into the treatment paradigm for multiple myeloma. Below is a summary of highlights from key oral and poster sessions focused on multiple myeloma. • The inclusion of Velcade (bortezomib) in an induction regimen prior to high-dose melphalan and stem cell transplant, as well as consolidation and maintenance therapy post-transplant, continues to lead to high response rates, particularly complete responses (CRs) and near CRs. Moreover, Velcade continues to work as or nearly as effectively in patients with high-risk features like the deletion of chromosome 13q or translocation of chromosomes 4 and 14, ie, t(4;14).• Maintenance therapy with Revlimid (lenalidomide) continues to delay disease progression (recurrence) when administered in low doses (5-15 mg continuously or for 21/28 days/month) following high-dose chemotherapy and autologous stem cell transplant. It is important to understand that we do not yet know if there is a survival benefit, and longer follow-up is needed. We also do not yet know if there are specific patients who are more likely to benefit from maintenance and/or if there are patients who may not need maintenance therapy given the low risk nature of their disease. The MMRF is committed to better understanding the right therapy for each patient and is investing in research to help answer these types of questions.• In standard-risk multiple myeloma patients, after three years of follow-up there was no benefit in terms of delay of disease progression or survival for patients who received an autologous stem cell transplant plus a mini-allogeneic transplant versus two autologous stem cell transplants. Given these results and the high rate of toxicities, any type of allogeneic transplant should be carefully discussed with your doctor and only considered within the context of a clinical trial. Follow-up of patients in the trial will continue should the long-term results yield new insights.• Encouraging results of a phase 2b study of carfilzomib, a next-generation proteasome inhibitor that was facilitated by the Multiple Myeloma Research Consortium, were presented. Of 257 patients evaluated in the study, patients had an overall response rate of 24% to carfilzomib and a median duration of response of more than 7 months. Notably, no patients discontinued treatment due to either new or worsening peripheral neuropathy. A separate analysis of patient responses revealed that patients who had high-risk features such as chromosome 13 deletions, deletion of chromosome 17p and/or t(4;14) or t(14;16) had similar response rates. Based on these positive results, Onyx, the manufacturer, expects to file for FDA approval sometime in 2011. Meanwhile, a phase 3 trial comparing carfilzomib/Revlimid/dexamethasone to Revlimid/dexamethasone is open and accruing patients.• New data from several trials involving the exciting new immunomodulating drug pomalidomide were also presented. The trials, conducted in the US (one of which was conducted through the MMRC) and in France, included patients who were refractory to both Velcade and Revlimid--patients who are in urgent need of new treatment options. Regardless of the dose schedule under study, at least 30% of patients receiving 4 mg in each trial responded to therapy. There was no evidence of the incidence or worsening of peripheral neuropathy. A phase 3 trial is expected to open in early 2011.• The novel therapy Zolinza (vorinostat), a histone deacetylase inhibitor, continues to appear to be a promising new option for myeloma patients in combination with standard therapies like Velcade and Revlimid. Poster presentations at ASH revealed compelling but early data on Zolinza in combination with Velcade and/or Revlimid, both for newly diagnosed and for relapsed/refractory patients. Excitingly, one trial, conducted in part through the MMRC, found it could re-sensitize Velcade-resistant patients to the combination of Velcade and Zolinza. This combination drug is being studied in a phase 3 trial and, if the results are promising, it could be FDA-approved for myeloma as early as 2012.• The results of a phase 2 study of elotuzumab in combination with Revlimid and dexamethasone, a trial that advanced from an earlier MMRC study, were presented. Although treated patients had not previously received Revlimid, the overall response rate was 85%, with a 31% very good partial response or complete response. This is a very early look at the data, but the results are encouraging. Additional data on early studies of elotuzumab plus Revlimid/dexamethasone, as well as elotuzumab plus Velcade/dexamethasone, both of which were advanced through the MMRC, show similarly encouraging data. A phase 3 clinical trial comparing elotuzumab/Revlimid/dexamethasone to Revlimid/dexamethasone is expected to open early next year.To learn more about these topics and to stay current on the latest multiple myeloma information, visit the MMRF's website at www.multiplemyeloma.org.

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