Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed 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: Newly diagnosed symptomatic multiple myeloma confirmed by the following: Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis No smoldering myeloma or monoclonal gammopathy of undetermined significance PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 50,000/mm^3 Hemoglobin greater than 7 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal Renal: Creatinine less than 3 mg/dL Cardiovascular: No prior or concurrent deep venous thrombosis Other: Prior malignancy allowed provided the following criteria are met: Received prior treatment with curative intent Free of disease for the time period appropriate for cure of the specific cancer No grade 2 or greater peripheral neuropathy due to other medical conditions No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for multiple myeloma No other concurrent biologic therapy for multiple myeloma Chemotherapy: No prior chemotherapy for multiple myeloma No other concurrent chemotherapy for multiple myeloma Endocrine therapy: More than 6 months since prior systemic dexamethasone or glucocorticoids No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior palliative, localized radiotherapy Concurrent palliative, localized radiotherapy allowed at the physician's discretion Surgery: Not specified Other: No prior systemic therapy for multiple myeloma, except bisphosphonates No concurrent anticoagulant therapy for deep vein thrombosis No concurrent barbiturates or alcohol (thalidomide arm)
Sites / Locations
- CCOP - Scottsdale Oncology Program
- City of Hope Comprehensive Cancer Center
- Veterans Affairs Medical Center - Palo Alto
- Stanford University Medical Center
- CCOP - Colorado Cancer Research Program, Inc.
- CCOP - Christiana Care Health Services
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Gainesville
- UF Shands Cancer Center
- Veterans Affairs Medical Center - Miami
- H. Lee Moffitt Cancer Center and Research Institute
- Veterans Affairs Medical Center - Tampa (Haley)
- Emory University Hospital - Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- CCOP - Central Illinois
- CCOP - Evanston
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Northern Indiana CR Consortium
- Hematology Oncology Associates of the Quad Cities
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Holden Comprehensive Cancer Center
- Veterans Affairs Medical Center - Wichita
- MBCCOP - LSU Medical Center
- CCOP - Ochsner
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tuft-New England Medical Center
- Beth Israel Deaconess Medical Center
- CCOP - Ann Arbor Regional
- CCOP - Kalamazoo
- CCOP - Duluth
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Veterans Affairs Medical Center - Omaha
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey
- Albert Einstein Clinical Cancer Center
- MBCCOP-Our Lady of Mercy Cancer Center
- Veterans Affairs Medical Center - Brooklyn
- Veterans Affairs Medical Center - New York
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- James P. Wilmot Cancer Center
- CCOP - Merit Care Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- CCOP - Toledo Community Hospital
- CCOP - Oklahoma
- CCOP - Geisinger Clinic and Medical Center
- Hahnemann University Hospital
- University of Pennsylvania Cancer Center
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute
- Veterans Affairs Medical Center - Pittsburgh
- CCOP - MainLine Health
- CCOP - Sioux Community Cancer Consortium
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- Vanderbilt-Ingram Cancer Center
- CCOP - Scott and White Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- Veterans Affairs Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- MBCCOP - San Juan
- Veterans Affairs Medical Center - San Juan
- Pretoria Academic Hospitals