Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated 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
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
Sites / Locations
- Alta Bates Summit Comprehensive Cancer Center
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Desert Regional Medical Center Comprehensive Cancer Center
- Sutter Cancer Center
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- St. Vincent's Comprehensive Cancer Center - Manhattan
- Oregon Health and Science University Cancer Institute
- Lone Star Oncology - Austin
- Seattle Cancer Care Alliance
- Fred Hutchinson Cancer Research Center