Mayo Clinic Research Shows Promise For Myeloma Patients Using A New Combination Of Drugs

"Previous studies have shown Rev/Dex to be effective for recurrentor highly resistant forms of myeloma," says S. Vincent Rajkumar, M.D.,Mayo Clinic hematological oncologist and lead investigator of thestudy, "In this study, the first one to use the combination as initialtherapy in newly diagnosed patients, we find that the Rev/Dexcombination reduced the myeloma cancer protein levels by more than halfin 91 percent of patients -- much higher than response rates obtainedwith current approved therapies."

The goal of this clinical trial was to determine the responserate and toxicity (type and severity of side effects) of Rev/Dex inpatients with previously untreated, newly diagnosed multiple myeloma.Over the course of the trial, 34 patients underwent the combinationtreatment, with 31 (91 percent) showing positive response to thetreatment, and all within a rapid period -- average response time wasone month. In addition to the quick and positive responses, sideeffects were manageable, and common ones associated with thalidomidetreatment, such as constipation, blood clots and neuropathy, wereuncommon. Rev/Dex is administered orally -- making it a more attractiveoption to many patients compared to traditional intravenous treatments.

"We see this as potentially the way of the future for manymyeloma patients," says Morie Gertz, M.D., Mayo hematologicaloncologist and co-investigator, "We are happy that two large Phase IIItrials are currently ongoing, moving forward the testing of Rev/Dex asinitial therapy for myeloma."

Multiple myeloma is a malignant cancer of the blood that causes11,000 deaths each year. Standard therapy of melphalan and prednisoneresults in about 50 percent of patients having a positive response --i.e. the cancer cells lessen by more than half. Vincristine,doxorubicin and dexamethasone (VAD) is another chemotherapy regimenused to treat myeloma, typically for patients who are candidates forstem cell transplantation because it allows adequate and safe stem cellharvest during treatment for a future transplantation. However, the useof VAD chemotherapy has decreased greatly because of the need forintravenous therapy and the need for a catheter -- bringing otherpotential health risks.

Recent studies have looked at the oral combination ofthalidomide and dexamethasone (Thal/Dex) as an alternative to VAD.Although response rates are excellent (approximately 70 percent), thecombination causes significant side effects. Lenalidomide is a compoundsimilar to thalidomide, but one which previous studies have shown towork better both for recurrent and highly resistant myelomas, bothalone and in conjunction with dexamethasone. It has fewer side effectsthan thalidomide and has even caused improvement in patients who arenonresponsive to thalidomide.

Lenalidomide is not commercially available; approval by theFood and Drug Administration is pending. The study was funded withgrants from the National Cancer Institute and Celgene Corporation,which manufactures RevlimidTM.

For more information on clinical trials at Mayo Clinic, go to http://clinicaltrials.mayo.edu, and for more information on treatment of multiple myeloma, go to www.mayoclinic.org/multiple-myeloma.

To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories.