Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Biological: filgrastim
* Drug: melphalan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: melphalan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma