Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With 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, defined by at least 2 of the following conditions: Neoplastic cell infiltrate and/or microplasmacytomas by bone marrow sections or smears Plasma cell infiltrates greater than 20% of marrow nucleated cells or, if less than 20%, objective evidence of monoclonality of the plasma cells required Paraprotein in blood or urine Definite lytic bone lesions (not osteoporosis) Nonsecretory disease allowed in the presence of 1 of the following conditions: Microplasmacytomas Monoclonal plasmacytosis with immunoglobulin light-chain expression in cytoplasm No equivocal myelomatosis, defined by the following criteria: Minimal or no symptoms attributable to myelomatosis Pretransfusion hemoglobin greater than 10 g/dL Post-hydration creatinine less than 1.47 mg/dL No osteolytic lesions except minimal lesions that do not threaten pathological fracture and are not associated with pain Plasma cells less than 30% of marrow nucleated cells and marrow showing normal hematopoietic activity Serum beta-2 microglobulin less than 4 mg/L Less than 1 g of free light-chain excretion per 1 g of creatinine No objective factors indicating progressive myelomatosis PATIENT CHARACTERISTICS: Age: 65 to 74 If under 65, higher priority is given to protocol MRC-LEUK-MYEL-VII unless entry into this study would be more appropriate Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Neutrophil count at least 1,300/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Not specified Renal: See Disease Characteristics Other: Ability to tolerate fluid intake of at least 3 L/day beginning at least 2 days before study entry Afebrile and free of infection No contraindication to therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior or concurrent prednisolone at 30 mg/m2/day or less (or equivalent doses of other corticosteroids) for relief of fluid-unresponsive hypercalcemia allowed Radiotherapy: Prior or concurrent minimal local radiotherapy to relieve persistent bone pain or cord compression allowed Surgery: Not specified
Sites / Locations
- MRC Myelomatosis Trials Office