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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenograstim; Melphalan

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