A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma requiring treatment
* Measurable secretory disease, defined as either serum M-protein \>=1 g/dL or urine M-protein (light chain) \>=¿200 mg/24 hours
* Must have received 1 to 3 lines of prior treatment for multiple myeloma
* Must have achieved a response (Minimal Response or better) to at least 1 prior line of treatment
* Must have progressed on or been refractory (defined as \< Minimal Response or disease progression within 60 days of last dose) to the most recent line of treatment
* Must not be refractory to any previous line of treatment that included a proteasome inhibitor
* Qualifying hematology and chemistry laboratory results.

Exclusion Criteria:

* Diagnosis of primary amyloidosis, plasma cell leukemia, or other conditions in which a paraprotein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy
* Allogeneic bone marrow transplantation within 28 days
* Bone marrow transplant planned within 12 months after study start
* Chemotherapy or radiation therapy within 21 days
* Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity
* Major surgery within 21 days before or planned during the study
* Subjects who the investigator believes would not tolerate starting doses of VELCADE or dexamethasone
* Significant cardiac disease or myocardial infarction within 6 months
* Vaccination with live attenuated vaccines within 4 weeks
* Prior exposure to agents targeting IL-6 or the IL-6 receptor
* Received any investigational agent within 30 days¿