Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
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Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of multiple myeloma
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Must have received induction therapy within the past 3 months
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Chemoresponsive disease
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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
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No symptomatic pleural effusions
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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:
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No symptomatic cardiomyopathy
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No medically documented symptomatic cardiac arrhythmias within the past 60 days
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No New York Heart Association class III congestive heart failure
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No myocardial infarction within the past 6 months
Other:
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No other concurrent medical conditions that would preclude study
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No uncontrolled infections
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Raymond L. Comenzo, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00-067
- CDR0000068392
- NCI-G00-1895