A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Siltuximab; Bortezomib; Placebo; Dexamethasone
Intervention description: Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2.; Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2.; Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2.; Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2.
Intervention MeSH terms: Dexamethasone; Bortezomib; Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: multiple myeloma; Monoclonal Antibody; Intravenous; refractory or relapsed multiple myeloma; velcade; bortezomib

Summary:

      The purpose of Part 1 of the study is to determine the safety of the combination of
      Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to
      compare the length of progression free survival for those patients given CNTO 328 and
      bortezomib to those patients given bortezomib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Measurable secretory disease defined as either serum monoclonal paraprotein,
             (M-protein) greater than or equal to (>=)1 gram per deciliter (g/dL) or urine
             monoclonal (light chain) protein (> 200 mg/24 hours)

          -  Documented disease progression after at least 1 prior line of therapy but no more than
             3 or have had no response to previous treatment (primary refractory disease)

          -  ECOG performance status score of less than or equal to (<=) 2

          -  Adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          -  No prior treatment with bortezomib

          -  Not Refractory to high-dose dexamethasone

          -  Not >= Grade 2 peripheral neuropathy

          -  Have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell
             transplant

          -  No prior or concomitant malignancy (other than multiple myeloma) except adequately
             treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the
             cervix, or other cancer for which the patient has been disease-free for <= 3 years