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Title:
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A Randomized Phase III Trial of CC-5-13 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant - IRB# 08-112A
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Treatments:
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Bortezomib (Velcade™, PS-341), Dexamethasone, Lenalidomide
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Disease Site:
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Multiple myeloma
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Disease SubSite:
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Drug Provided:
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Bortezomib (Velcade™, PS-341), Lenalidomide
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Comments:
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Eligibility:
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Newly diagnosed multiple myeloma (MM). Stage I, II, or III disease by the New International Staging System. Measurable disease, Nonsecretory MM based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is elevated. Must be offered participation in the Myeloma Specimen Repository for banking and future research. Institutions must submit a local cytogenetics report and FISH analysis prior to study entry. Prior/Concurrent Therapy: No prior chemotherapy for this disease. No prior radiotherapy to a large area of the pelvis (i.e., more than half of the pelvis). No prior bortezomib or lenalidomide. Prior steroid treatment allowed provided treatment was no more than 2 weeks in duration. Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously daily if allergic to aspirin) as prophylactic coagulation.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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