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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Treatments: Biological: filgrastim; Drug: melphalan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00008268

00-067

CDR0000068392 (Registry Identifier)

NCI-G00-1895

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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