Clinical trial NCT00128921 (phase 2, status: terminated)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: velcade™
SMILES: CC(C)C[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)C1=CN=CC=N1)B(O)O
Reason stopped: 
    study terminated due to low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  History of histologically documented MM with relapsed or progressive disease after at
             least one line of prior therapy.

          -  Patient has measurable disease in which to capture response, defined as one or more of
             the following:

               -  Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein
                  electrophoresis or immunoglobulin electrophoresis; or

               -  Urinary M-protein excretion > 1000 mg/24 hours; or

               -  Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or

               -  Serum free light chains (by the Freelite test) > 2 X the upper limit of normal,
                  in the absence of renal failure.

               -  Evidence of active disease by radiographic techniques

          -  Performance status (PS) of <= 2 as per Southwest Oncology Group scale, unless PS of
             3-4 based solely on bone pain.

          -  Patients must have a platelet count >= 50,000/mm3, and an absolute neutrophil count of
             at least 1,000/μl.

          -  Patients must have adequate renal function defined as creatinine clearance > 30ml/min.

          -  Patients must have adequate hepatic function defined as serum transaminases and direct
             bilirubin < 2 X the upper limit of normal.

          -  Pregnant or nursing women may not participate. Women of childbearing potential must
             have a negative pregnancy test documented within one week of registration. Women of
             reproductive potential may not participate unless they have agreed to use an effective
             contraceptive method.

          -  Male or female adults of at least 18 years of age.

          -  Patients must have signed and Institutional Review Board approved written informed
             consent form and demonstrate willingness to meet follow-up schedule and study
             procedure obligations

        Exclusion Criteria:

          -  Chemotherapy or radiotherapy received within the previous 4 weeks.

          -  Has received previous bortezomib therapy

          -  Significant neurotoxicity, defined as grade > 2 neurotoxicity per National Cancer
             Institute Common Toxicity Criteria.

          -  Platelet count < 50,000/mm3, or ANC < 1,000/μl

          -  Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes
             syndrome.

          -  Patient has hypersensitivity to bortezomib, boron, or mannitol

          -  Clinically significant hepatic dysfunction as noted by bilirubin or AST >3 times the
             upper normal limit or clinically significant concurrent hepatitis.

          -  New York Hospital Association Class III or Class IV heart failure.

          -  Myocardial infarction within the last 6 months.

          -  Non-secretory multiple myeloma, unless the patient has measurable lesions on computed
             tomography, magnetic resonance imaging and/or positron emission tomography.

          -  Uncontrolled, active infection.

          -  Patients with a history of treatment for clinically significant ventricular cardiac
             arrhythmias.

          -  Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric
             illness that could potentially interfere with the completion of treatment according to
             this protocol.

          -  Pregnant or potential for pregnancy. Women of childbearing potential will have a
             pregnancy [beta-HCG] test at screening, and will be required to use a medically
             approved contraceptive method. Pregnancy testing will be performed prior to
             administration of each cycle of study drug.

          -  Breast-feeding women may not participate.