Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, SCIO-469, p38 MAP kinase, myeloma, bone marrow
Eligibility Criteria
Inclusion Criteria: Life expectancy more than three months diagnosed with multiple myeloma (MM) relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy Karnofsky performance status = 60 no electrocardiographic evidence of acute ischemia or new conduction system abnormalities no history of myocardial infarction within last 6 months serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN) total serum bilirubin = 2X ULN Calculated or measured creatinine clearance >30 mL/min platelet count = 30 x 10(9)/L hemoglobin concentration = 8 g/dL white blood cell count = 2.0 x 10(9)/L Exclusion Criteria: Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes) major surgery within four weeks of enrollment severe elevated serum calcium heart failure receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment known allergies to agents used in bortezomib (e.g., boron or mannitol) poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
001
002
SCIO-469 two 30-mg capsules three times daily
SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period