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

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if there is an improvement in progression-free survival (length of time during and after treatment in which a patient is living with a disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in subjects with relapsed or refractory multiple myeloma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Siltuximab

Criteria

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¿