A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Siltuximab11 mg/kg; Siltuximab 8.3 mg/kg or 11 mg/kg; Velcade (bortezomib); Velcade (bortezomib); Melphalan; Melphalan; Prednisone; Prednisone; Velcade (bortezomib); Melphalan; Prednisone
Intervention description: Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1.; Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period.; Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1.; Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period); Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.; Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A.; Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.; Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A.; Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert.; Participants will take melphalan 9 mg/m2 orally according to currently approved package insert.; Participants will take prednisone 60 mg/m2 orally according to the package insert.
Intervention MeSH terms: Prednisone; Bortezomib; Melphalan; Siltuximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; CNTO328; Interleukin-6 (IL-6); Monoclonal antibody; Anti-IL-6 monoclonal antibody; Bortezomib; Velcade; Melphalan; Prednisone

Summary:

      The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab)
      when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with
      VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and
      bone marrow).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for
             high dose chemotherapy with stem cell transplantation

          -  Eastern cooperative oncology group performance status score of less than or equal to 2

          -  Measurable secretory disease, defined as either serum monoclonal paraprotein greater
             than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours

          -  Adequate laboratory results that will be confirmed by a study physician

          -  Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

          -  Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or
             monoclonal gammopathy of undetermined significance

          -  Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is
             present in the absence of a clonal plasma cell infiltration with lytic bone lesions

          -  Received prior or current systemic therapy or stem cell transplantation for multiple
             myeloma

          -  Peripheral neuropathy or neuropathic pain (Grade 2 or higher)

          -  Received radiation therapy, plasmapheresis or surgery within 14 days

          -  Transplanted solid organ, with the exception of a corneal transplant

          -  Serious concurrent illness or history of uncontrolled heart disease