Clinical trial NCT00573391 (phase 3, status: terminated)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: velcade, thalidomide, and dexamethasone, velcade, melphalan, and dexamethasone
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  History of histologically documented MM previously enrolled on UARK 98-026 with
             relapsed or progressive disease after at least one autologous transplant.

          -  Patient has measurable disease in which to capture response, defined as:

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

          -  Urinary M-protein excretion > 200 mg/24 hrs

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

          -  Serum Free Light Chains (By the Freelite test) > 10 mg/dL with an abnormal
             kappa/lambda ration.

          -  50percent increase in size of lytic and/or focal lesions or development of new lesions
             recognized by radiographic studies.

          -  Performance status of 2 as per SWOG scale, unless PS of 3-4 based solely on bone pain.

          -  Patients must have a platelet count 50,000/mm3, unless the low platelet count is due
             to documented (>30 percent) extensive myeloma infiltration of the bone marrow.

          -  Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.

          -  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 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 IRB-approved written informed consent form and
             demonstrate willingness to meet follow-up schedule and study procedure obligations

          -  > 5 x 106 CD34 cells/kg in storage strongly desired, but not mandated

        Exclusion Criteria:

          -  Not previously enrolled on UARK 98-026.

          -  Has received salvage therapy after coming off UARK 98-026.

          -  Evidence of POEMS Syndrome..

          -  Significant neurotoxicity interfering with ADL.

          -  Platelet count < 50,000/mm3

          -  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 (NYHA) Class III or Class IV heart failure.

          -  Myocardial infarction within the last 6 months.

          -  Truly non-secretory MM (no increase in serum free-light chains) in the absence of bone
             marrow plasmacytosis and MRI-defined focal lesions with CT-FNA-proven MM

          -  Uncontrolled, active infection requiring IV antibiotics.

          -  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 test at screening, and will be required to use a medically approved
             contraceptive method. Pregnancy testing will be performed prior to administration of
             each dose of study drug.

          -  Breast-feeding women may not participate.