Clinical trial NCT00438841 (phase 2, status: unknown status)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: bortezomib, cyclophosphamide, dexamethasone, thalidomide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of multiple myeloma meeting 1 of the following criteria:

               -  Monoclonal immunoglobulin spike on serum electrophoresis (IgG > 3.5 g/dL or IgA >
                  2.0 g/dL) and kappa or lambda light chain excretion > 1 g/day by 24-hour urine
                  protein electrophoresis AND meets any of the following criteria:

                    -  Bone marrow plasmacytosis (10-30% plasma cells)

                    -  Lytic bone lesions

               -  Monoclonal immunoglobulin of lesser magnitude present and bone marrow
                  plasmacytosis (10-30% plasma cells) AND meets any of the following criteria:

                    -  Lytic bone lesions

                    -  IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

               -  Bone marrow plasmacytosis (> 30% plasma cells) or plasmacytoma on tissue biopsy
                  AND meets any of the following criteria:

                    -  Monoclonal immunoglobulin of lesser magnitude present

                    -  Lytic bone lesions

                    -  IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

               -  FreeLite testing abnormal and kappa:lambda light chain ratio abnormal

          -  Symptomatic disease requiring treatment

               -  Documented related organ or tissue involvement, if present

          -  Measurable disease, defined as 1 of the following:

               -  Monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine
                  monoclonal immunoglobulin spike ≥ 200 mg/day

               -  Abnormal FreeLite testing (for nonsecretors)

               -  Patients with nonsecretory disease must meet either of the following criteria for
                  measurability:

                    -  Has measurable protein by FreeLite testing

                    -  Untreated soft tissue plasmacytoma and/or evaluable disease in bone marrow

          -  Newly diagnosed, previously untreated disease

          -  No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly,
             endocrinopathy, monoclonal protein [M-protein], and skin changes)

          -  No plasma cell leukemia

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 50-100%

          -  Platelet count ≥ 100,000/mm³ (≥ 50,000/mm³ if bone marrow is extensively infiltrated)

               -  Extensive infiltration is defined as > 50% myeloma cells or plasma cells

          -  Hemoglobin ≥ 8.5 g/dL

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  AST and ALT ≤ 2 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN (unless clearly related to the disease)

          -  Creatinine clearance ≥ 20 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 methods of effective contraception ≥ 4 weeks prior to
             beginning treatment, during, and for ≥ 4 weeks after completion of study treatment

          -  No impaired kidney function requiring dialysis

          -  No uncontrolled infection

          -  No HIV positivity

          -  No known active hepatitis B or C

          -  No cardiovascular disease including, but not limited to, any of the following:

               -  Myocardial infarction within the past 6 months

               -  New York Heart Association class II-IV heart failure

               -  Uncontrolled angina

               -  Severe uncontrolled ventricular arrhythmias

               -  Clinically significant pericardial disease

               -  Acute ischemic or active conduction system abnormalities by EKG

          -  No history of allergic reactions to compounds containing mannitol, bortezomib, or
             cyclophosphamide

          -  No second malignancy requiring concurrent treatment

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

          -  No peripheral neuropathy ≥ grade 1

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy, immunotherapy, vaccine therapy, therapeutic doses of steroids,
             or other agents for the treatment of active myeloma

               -  Drugs given to prevent onset of myeloma allowed

               -  Bisphosphonates for hypercalcemia or short course corticosteroids for
                  hypercalcemia or cord compromise allowed

          -  Prior local radiotherapy with or without a brief exposure to steroids allowed

          -  More than 4 weeks since prior and no concurrent radiotherapy

               -  Spot radiotherapy to ≤ 3 vertebrae allowed

          -  No concurrent steroids at > 10 mg of prednisone daily (or the equivalent) for other
             medical conditions (e.g., asthma, systemic lupus erythematosus, or rheumatoid
             arthritis)

          -  No other concurrent chemotherapy or investigational agents

          -  Concurrent daily acetylsalicylic acid required during course 4-6 of study treatment