Status:
COMPLETED
Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
Lead Sponsor:
Scios, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00087867
Start Date
June 1 2004
End Date
September 1 2005
Last Update
October 18 2010
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