Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• Must be ≥ 18 years at the time of signing informed consent.
• Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
• Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
• Must have documented disease progression during or after their last anti-myeloma therapy.
• All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria

• Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
• Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
• Non-secretory multiple myeloma.
• Subjects with severe renal impairment requiring dialysis.
• Previous therapy with pomalidomide.