Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00008268


Primary Contact:

Study Chair
Raymond L. Comenzo, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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