Clinical trial NCT00504101 (phase 1, status: withdrawn)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: arsenic trioxide, bortezomib, melphalan
SMILES: O=[As]O[As]=O, ClCCN(CCCl)P1(=O)NCCCO1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    temporarily closed to accrual pending availablity of drug.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or
             urine protein electrophoresis) and either bone marrow biopsy and aspirate
             demonstrating a plasma cell count > 10% or biopsy of a bone or soft tissue mass
             demonstrating a plasmacytoma

               -  Demonstration of an indication for therapy based on symptoms (e.g., boney pain),
                  hypercalcemia, anemia, renal insufficiency, symptomatic plasmacytomas, multiple
                  boney lytic lesions, etc

               -  Stable disease or has achieved a partial remission or complete remission to
                  pre-transplant cyto-reductive therapy

               -  Primary refractory disease (no response to therapy but stable) is permitted

          -  Candidate for high-dose chemotherapy with autologous stem cell transplantation based
             on stabilization of disease with preparative chemotherapy (regardless of the specific
             agents)

          -  A minimum of 2 x 10^6 CD34+ cells/kg must be collected prior to proceeding to
             transplant

        Exclusion criteria:

          -  Evidence of active plasma cell leukemia

          -  Relapsed refractory disease (patients who have achieved at least a partial response
             [PR] to previous therapy and are now refractory [have not achieved a PR to subsequent
             therapy])

          -  Progressive disease on their last therapy

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Karnofsky performance status 60-100%

          -  Creatinine < 3.0 mg/dL

          -  AST and ALT <2.5 times upper limit of normal

          -  Total bilirubin < 3 mg/dL

          -  WBC ≥ 2,000/mm³

          -  Platelet count ≥ 50,000/mm³

          -  If abnormal hematologic function is attributable to bone marrow infiltration by
             multiple myeloma, the principal investigator will decide on a case-by-case basis if
             the patient's bone marrow reserve is appropriate for this study

          -  Females of childbearing potential must have a negative serum pregnancy test prior to
             enrollment on the study and must use an effective barrier method while on the study

          -  Ejection fraction > 40% and no history of uncontrolled ischemic heart disease or
             congestive heart failure

          -  No evidence of cardiac amyloidosis by echocardiogram

          -  DLCO and FEV_1 ≥ 50%

        Exclusion criteria:

          -  Active peripheral neuropathy ≥ grade 2

          -  Recurrent supraventricular arrhythmia or any type of sustained ventricular arrhythmia
             or conduction block (e.g., A-V block grade II or III, left bundle branch block)

          -  Known HIV infection

          -  Pregnant or lactating women

          -  Underlying medical condition that could be aggravated by the treatment or
             life-threatening disease unrelated to myeloma as evaluated by the enrolling physician

          -  History of second malignancy within the past 3 years and not in complete remission
             from that malignancy, excluding adequately treated basal or squamous cell carcinoma of
             the skin, carcinoma in situ of the cervix, or local prostate cancer

          -  History of preexisting neurological disorders (grade 2 or higher by the NCI Common
             Toxicity Criteria, in particular seizure disorders)

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  Previous radiation therapy for palliation of cord compression or pathologic fractures
             is permitted provided last dose is given 14 days prior to initiation of chemotherapy

          -  Subjects with radiographic evidence of lytic bone disease receiving concomitant
             bisphosphonate therapy may be enrolled

               -  Bisphosphonates should be held at least 1 week prior to the transplant but
                  continuing bisphosphonates after day +60 is at the discretion of the treating
                  physician

        Exclusion criteria:

          -  Previous autologous or allogeneic transplantation

          -  Other investigational or experimental drug or therapy while on the study