A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma

Pts must have a confirmed diagnosis of previously treated, active multiple myeloma with measurable disease present to evaluate response as defined in the protocol. Pts must have relapsed or resistant disease, as defined in the protocol. Pts must be off chemotherapy and XRT for greater than or equal to 14 days (greater than or equal to 28 days for nitrosoureas) and recovered from all treatment associated toxicities prior to registration. Zubrod PS 0-2; Zubrod PS of 3-4 based solely on bone pain eligible. Pts must have received no prior treatment with bortezomib and/or combination of bortezomib/thalidomide. Pts must have no current significant neurotoxicity, as defined in the protocol. Pts must have no evidence of POEMS Syndrome. There must be no active infection requiring antibiotics. Pts must have bilirubin or AST less than or equal to 3 x the IULN within 28 days prior to registration. Pts must have creatinine clearance greater than 30 cc/min within 28 days prior to registration. Pts must have an ANC greater than 1,000/ul and platelet count greater than 50,000/ul within 14 days prior to registration. Pts must not have NYHA Class III or Class IV heart failure. Pts must not have had a myocardial infarction within the last 6 months. Pts must not have poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the pt has been disease free for at least 3 years. Pt must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. Pts must be fully aware of teratogenic potential of thalidomide and agree to fully comply with the guidelines regarding contraception in the informed consent and the patient warning letter attached to the consent form. Pts must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program. Institutions must have IRB approval of S0309 and S0334. Pts must be offered participation in S0309 and S0334.