Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosed with multiple myeloma by 1 of the following criteria: Meets any 2 of the following major criteria: Plasmacytomas on tissue biopsy Bone marrow plasmacytosis (i.e., > 30% plasma cells) Monoclonal immunoglobulin spike IgG > 3.5 g/dL or IgA > 2.0 g/dL by serum electrophoresis; kappa or lambda light chain excretion > 1 g by 24-hour urine protein electrophoresis Plasmacytomas on tissue biopsy AND meets any 1 of the following minor criteria: Presence of monoclonal immunoglobulin at a lesser magnitude than given under above major criteria Lytic bone lesions Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL Monoclonal immunoglobulin spike IgG > 3.5 g/dL or IgA > 2.0 g/dL by serum electrophoresis; kappa or lambda light chain excretion > 1 g by 24-hour urine protein electrophoresis AND meets 1 of the following minor criteria: Bone marrow plasmacytosis (i.e., 10-30% plasma cells) Lytic bone lesions Presence of monoclonal immunoglobulin at a lesser magnitude than given under major criteria with bone marrow plasmacytosis (i.e., 10-30% plasma cells) AND meets 1 of the following minor criteria: Lytic bone lesions Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL Measurable disease, defined as a monoclonal immunoglobulin spike of ≥ 1 gm/dL by serum electrophoresis and/or a immunoglobulin spike of ≥ 200 mg by 24-hour urine protein electrophoresis or evidence of lytic bone disease OR Nonmeasurable disease (i.e., patients with nonsecretory or oligosecretory multiple myeloma) Relapsed or refractory disease Relapsed disease following a response or stable disease after prior chemotherapy (e.g., single-agent steroids, vincristine, doxorubicin, and dexamethasone [VAD], or melphalan and prednisone [MP]) or high-dose chemotherapy Refractory (i.e., failure to achieve at least complete or partial response or stable disease) to the most recent chemotherapy with or without systemic corticosteroids No plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS syndrome) No extramedullary myeloma PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Life expectancy > 3 months Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 75,000/mm³ AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ 2 times ULN (unless clearly related to disease) Creatinine clearance ≥ 30 mL/min Creatinine clearance > 15 mL/min and < 30 mL/min due to significant myelomatous involvement of kidneys allowed at discretion of investigator Sodium > 130 mmol/L No ECG evidence of acute ischemia or new conduction system abnormalities No myocardial infarction within the past 6 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL) No New York Hospital Association class III or IV heart failure No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that would preclude study treatment No known HIV history No known active hepatitis B or C viral infection No history of allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib, boron, mannitol, ethylenediaminetetramethylenephosphonic acid (EDTMP), or phosphonates No peripheral neuropathy > grade 1 PRIOR CONCURRENT THERAPY: At least 12 weeks since prior samarium Sm 153 lexidronam pentasodium No more than 1 prior treatment At least 24 weeks since prior strontium chloride Sr 89 No more than 1 prior treatment No major surgery within the past 4 weeks No chemotherapy within the past 3 weeks (6 weeks for nitrosoureas) No corticosteroids (> 10 mg/day prednisone or equivalent) within the past 3 weeks No immunotherapy, antibody therapy, or radiotherapy (except localized radiotherapy) within the past 4 weeks No other concurrent investigational agents No concurrent corticosteroids (≥ 10 mg prednisone or equivalent)
Sites / Locations
- Comprehensive Blood and Cancer Center
- Hematology-Oncology Medical Group of Fresno, Incorporated
- Center for Cancer and Blood Disorders at Suburban Hospital