Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Bortezomib

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