An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
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 capsules (60 mg) by mouth three times a day with water, preferably with a
meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination
therapy. On these days, the second dose of SCIO-469 was administered after collection of the
12-hour PK sample, and the third dose was not administered.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
Scios, Inc. Clinical Trial
United States: Food and Drug Administration