Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Brief 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.
Detailed description
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.
Interventions
DRUGO6-benzylguanine
Patients receive O6-benzylguanine 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.
DRUGcarmustine
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.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma. | Every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response. Patients are followed every 2 months. |
Countries
United States
Outcome results
None listed