A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib
Intervention description: Bortezomib 1.3 mg per (m^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
Intervention MeSH terms: Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Bortezomib; Velcade

Summary:

      The purpose of this post marketing study is to determine the plasma concentration of
      bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug
      enters and leaves the blood and tissues over time) properties in the Taiwanese population. It
      will also provide expanded access (expanded access, sometimes called "compassionate use," is
      the use of an investigational drug outside of a clinical trial to treat a participant with a
      serious or immediately life-threatening disease or condition who has no comparable or
      satisfactory alternative treatment options) to bortezomib for the same group of participants
      with multiple myeloma (cancer of the types of cells normally found in bone marrow).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants previously diagnosed with multiple myeloma based on standard criteria

          -  Participant has received at least 2 previous lines of therapy for multiple myeloma
             and, in the Investigator's opinion, currently requires therapy because of relapsed
             (the return of a medical problem) or progressive disease

          -  Female participants either postmenopausal or surgically sterilized or willing to use
             an acceptable method of birth control from Screening through the Final Visit

          -  If male, the participant agrees to use an acceptable barrier method for contraception
             from Screening through the Final Visit

          -  Participant has a Karnofsky performance status classifies participants as to their
             functional impairment and is used to compare effectiveness of different therapies and
             to assess the prognosis [outlook, probable outcomes] in individual participants)
             greater than 60

        Exclusion Criteria:

          -  If the participant received bortezomib in a previous trial, the Participants' best
             response to bortezomib must be progressive disease

          -  If the participant received bortezomib in a previous trial, the participant must have
             experienced 1 or more serious adverse events

          -  Participants who have received nitrosoureas within 6 weeks or any other chemotherapy
             (treatment of disease, usually cancer, by chemical agents) within 3 weeks before
             enrollment

          -  Participants who have received corticosteroids (greater than 10 milligram per day
             prednisone or equivalent) within 3 weeks before enrollment

          -  Human Immunodeficiency Virus (HIV - a life-threatening infection which you can get
             from an infected person's blood or from having sex with an infected person)-positive
             or hepatitis-B surface antigen-positive participants or participants with known active
             hepatitis-C infection