CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Niigata Cancer Center Hospital
Niigata, Japan
DLT
Time frame: first cycle (28 days)
Efficacy (M-protein)
Time frame: 24 weeks
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Keio University Hospital
Tokyo, Japan