An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dexamethasone; Bortezomib
Intervention description: Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).; Bortezomib 1.3 milligram per meter^2 (mg/m^2), bolus intravenous injection will be administered on Days 1, 4, 8 and 11 of each 21-day cycle and up to 8 cycles.
Intervention MeSH terms: Dexamethasone; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Velcade; Bortezomib; Dexamethasone

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of bortezomib in
      participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow
      causing numerous tumors and characterized by the presence of abnormal proteins in the blood)
      with limited kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with symptomatic multiple myeloma based on the International
             Myeloma Working Group (IMWG) criteria; greater than or equal to 10 percent plasma
             cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum
             or urine and the, presence of end-organ injury

          -  Participants with measurable disease defined by at least 1 of the following 5
             measurements: a) serum M-protein greater than or equal to 1 gram per deciliter (g/dl),
             b) Urine M Protein greater than or equal to 200 milligram per 24 hour, c) Serum free
             light chain (FLC) assay: Involved FLC level greater than 10 mg per dl (mg/dl) provided
             serum FLC ratio is abnormal, d) Bone marrow plasma cells greater than or equal to 30
             percent

          -  Participants who received at least 1 prior line of chemotherapy for multiple myeloma
             and, is refractory to or has relapsed after the last therapy

          -  Participants with Karnofsky performance status greater than 60 or Eastern Cooperative
             Oncology Group (ECOG) performance status of 0-2

          -  Participants with calculated or measured creatinine clearance of less than or equal to
             30 mililiter per minute (ml/min). During the screening period, 2 measures of
             creatinine clearance at least 7 days apart must be obtained, and both must be less
             than 30 ml/min

        Exclusion Criteria:

          -  Participants who had received bortezomib in previous clinical trial and best response
             was progressive disease or experienced one or more serious events

          -  Participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of
             intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before
             enrolment

          -  Participants with history of allergic reaction attributable to compounds containing
             boron or mannitol

          -  Participants with peripheral neuropathy of Grade 2 or greater intensity at the time of
             signing informed consent form

          -  Pregnant or breast-feeding female participants