o6-benzylguanine and carmustine in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining o6-benzylguanine with carmustine in treating patients who have previously untreated, refractory, or relapsing multiple myeloma.

objectives: * evaluate the efficacy of o6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma. * assess the effects of o6-benzylguanine on bone marrow myeloma cells in this patient population. outline: patients receive o6-benzylguanine iv over 60 minutes followed 1 hour later by carmustine iv over 60 minutes. courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. patients receive 2 additional courses beyond attainment of best response (partial or complete response or stable or plateau disease). patients are followed every 2 months. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria: * previously untreated * primary refractory * relapsing disease * major criteria: * plasmacytomas on tissue biopsy * bone marrow plasmacytosis with greater than 30% plasma cells * monoclonal globulin spike on serum electrophoresis * greater than 3.5 g/dl for g peaks or greater than 2.0 g for a peaks * greater than 1.0 g/24 hours of kappa or lambda light chain excretion on urine electrophoresis in the absence of amyloidosis * minor criteria: * 10%-30% bone marrow plasmacytosis (criterion a) * presence of monoclonal globulin spike but less than the levels under major criteria (criterion b) * lytic bone lesions (criterion c) * igm less than 50 mg/dl, iga less than 100 mg/dl, or igg less than 600 mg/dl (criterion d) * must meet one of the following: * a minimum of 1 major criterion and 1 minor criterion * 3 minor criteria, including criteria a and b patient characteristics: age: * not specified performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 100,000/mm\^3 * absolute neutrophil count greater than 1,500/mm\^3 * hemoglobin greater than 9 g/dl (transfusions allowed) hepatic: * bilirubin less than 1.5 mg/dl * ast/alt less than 2 times normal renal: * creatinine no greater than 2.0 mg/dl or * creatinine clearance greater than 60 ml/min * calcium less than 14 mg/dl pulmonary: * no prior or concurrent active, symptomatic respiratory disease * corrected dlco at least 60% predicted other: * controlled diabetes mellitus allowed * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after study participation prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no more than 1 prior chemotherapy regimen containing an alkylating agent for multiple myeloma * at least 4 weeks since prior chemotherapy endocrine therapy: * prior corticosteroids for multiple myeloma allowed radiotherapy: * no prior pelvic radiotherapy or radiotherapy to more than 25% of bone marrow surgery: * not specified

Keywords: refractory multiple myeloma stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma