A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma

Pts must have a confirmed diagnosis of previously treated, active multiple myeloma, with measurable disease present to evaluate response. All tests for baseline disease status must be done within 28 days prior to registration. Pts must have relapsed or resistant disease. Pts must be off myelosuppressive chemotherapy for greater than or equal to 21 days (greater than or equal to 6 weeks for nitrosoureas) and non-myelosuppressive chemotherapy and XRT for greater than or equal to 14 days and recovered from all treatment associated toxicities prior to registration. Zubrod PS of 0-2. Pts must have received no prior treatment with BAY 43-9006 (sorafenib). Pts must be greater than or equal to 18 years of age at the time of enrollment. Pts must currently have no significant neurotoxicity, defined as Grade greater than or equal to 2 neurotoxicity per NCI CTCAE Version 3.0. Pts must have no evidence of POEMS Syndrome. There must be no active infection requiring antibiotics. Pts must have bilirubin less than or equal to 1.5 times the IULN and/or AST (SGOT or SGPT) less than or equal to 5 times the IULN within 28 days prior to registration. Pts must have serum creatinine less than or equal to the IULN within 28 days prior to registration. Pts must have an ANC greater than 750/ul and platelet count greater than 75,000/ul within 28 days prior to registration. Pts must be able to take oral medication without crushing, dissolving or chewing tablets. Pts must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, or St. John's Wort. Pts must not have a significant history of cardiac disease. Pts must not have any evidence of bleeding diathesis, uncontrolled diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. Pts must not be on therapeutic anitcoagulation. 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. Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Institutions must have IRB approval of S0309. Pts must be offered participation in S0309.