Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma

Inclusion Criteria

• •Cytologically or histologically confirmed diagnosis of multiple myeloma
• •Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment (i.e., achieved a minimal response \[MR\] or better) according to the International Myeloma Working Group (IMWG) uniform response criteria
• •Subjects must have had progressive disease according to the IMWG uniform response criteria following the last multiple myeloma treatment
• •Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results):
• •* Serum M-protein ≥1 g/dL
• •* Urine M-protein ≥200 mg/24 hours
• •* Serum free light chain (FLC) ≥10 mg/dL with abnormal ratio
• •≥1 bone lesion identifiable by radiograph, computed tomography, magnetic resonance imaging, or bone scintigraphy
• •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
• •Subjects must be nonrefractory to bortezomib and had no progression during or within 60 days after completion of bortezomib
• •Absolute neutrophil count (ANC) ≥1.5 × 10e9/L, hemoglobin (Hb) ≥9.0 g/dL, and platelet count ≥75.0 × 10e9/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF)