Clinical trial NCT00124579 (phase 2, status: terminated)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: bortezomib, dexamethasone, thalidomide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of multiple myeloma (MM)

               -  Active disease

          -  Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included
             autologous or allogeneic stem cell transplantation

               -  Relapse is defined as the occurrence of any of the following during or after
                  prior treatment:

                    -  Myeloma protein level increase by > 100% from the lowest previously recorded
                       level

                    -  Myeloma protein level increase above the defined response criteria for
                       partial remission

                    -  Reappearance of any myeloma peak that had disappeared during the prior
                       treatment

                    -  Increase in the size and number of lytic bone lesions and/or focal lesions
                       by x-ray, MRI, positron emission tomography, and/or CT scan

               -  Refractory disease is defined as no response (i.e., not achieving complete
                  remission, remission, or partial remission) to prior therapy

          -  Measurable disease

          -  No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of
             M-protein, and skin changes) syndrome

          -  Must be registered on protocol SWOG-S0334

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2 (unless due to bone pain)

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count > 1,000/mm^3

          -  Platelet count > 50,000/mm^3

        Hepatic

          -  AST or ALT ≤ 3 times upper limit of normal (ULN)

          -  Bilirubin ≤ 3 times ULN

        Renal

          -  Creatinine clearance > 30 mL/min

        Cardiovascular

          -  No New York Heart Association class III or IV congestive heart failure

          -  No myocardial infarction within the past 6 months

          -  No poorly controlled hypertension

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile female patients must use effective double method contraception for ≥ 4 weeks
             before, during, and for ≥ 4 weeks after completion of study treatment (during and for
             4 weeks after completion of study treatment for male patients)

          -  No blood, ova, or sperm donation during study treatment

          -  No active infection requiring antibiotics

          -  No neurotoxicity ≥ grade 2

          -  No diabetes mellitus

          -  No other serious medical or psychiatric illness that would preclude study treatment

          -  No other malignancy within the past 3 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

        Chemotherapy

          -  At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 14 days since prior radiotherapy and recovered

        Surgery

          -  Not specified

        Other

          -  No prior bortezomib alone or combined with thalidomide

          -  Concurrent participation on protocol SWOG-S0309 allowed