Table 2.

Patient Selection Criteria in Phase 3 Trial¹¹

Inclusion Criteria Patients with relapsed multiple myeloma and measurable disease who had received one to three prior treatments Patients previously treated with bortezomib who did not have disease progression throughout the study Patients previously treated with lenalidomide and dexamethasone, but only if they did not discontinue treatment due to adverse events, have disease progression within three months of therapy, or have disease progression if lenalidomide plus dexamethasone was their most recent treatment Patients with adequate hepatic, hematologic, and renal function (creatinine clearance ≥ 50 ml/min) at screening

Exclusion Criteria Grade 3 or 4 peripheral neuropathy (or grade 2 with pain) within 14 days before randomization or New York Heart Association Class III or IV heart failure