Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diag… (NCT00438841) | Clinical Trial Compass
UnknownPhase 2
Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma
United States43 participantsStarted 2006-08
Plain-language summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly diagnosed, previously untreated multiple myeloma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 so…