Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Brief summary
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.
Detailed description
OBJECTIVES: * Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma. * Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients. * Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients. OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.
Interventions
BIOLOGICALfilgrastim
DRUGmelphalan
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Must have received induction therapy within the past 3 months * Chemoresponsive disease * Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory * No symptomatic pleural effusions * Eligible for stem cell transplantation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy) Life expectancy: * Not specified Hematopoietic: * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance greater than 51 mL/min Cardiovascular: * No symptomatic cardiomyopathy * No medically documented symptomatic cardiac arrhythmias within the past 60 days * No New York Heart Association class III congestive heart failure * No myocardial infarction within the past 6 months Other: * No other concurrent medical conditions that would preclude study * No uncontrolled infections * No other active malignancy within the past 5 years except for non-melanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior stem cell mobilization or transplantation Chemotherapy: * See Disease Characteristics * No more than 200 mg prior oral melphalan Endocrine therapy: * Not specified Radiotherapy: * No more than 3000 cGy of prior radiotherapy for myeloma Surgery: * Not specified
Countries
United States
Outcome results
None listed