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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
two 30-mg capsules three times daily
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
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.
Time frame: Day 73
Time to first response, time to best response, and percentage of patients with disease progression were assessed.
Time frame: Days 1, 15, 30, 52, and 73
Size and number of lytic bone lesions were summarized.
Time frame: screening and Day 73
Quality of life and pain was assessed.
Time frame: Days 1, 15,30,52,73
Performance status was evaluated.
Time frame: Screening, Days 1, 30, 73
Bone disease was monitored by assessing various markers.
Time frame: Days 1, 15, 30, 52, 73
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