• Feasibility and tolerability 3 months after treatment and annually [ Designated as safety issue: Yes ]
  
• Response and durability of response 3 months after treatment and annually [ Designated as safety issue: No ]
  
• Evaluate immune reconstitution 3 months after treatment and annually [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis.
• Determine the response rate and durability of response in patients treated with this regimen.
• Determine immune reconstitution in patients treated with this regimen.

OUTLINE:

• Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection.
• Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2.
• Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0.

Patients are followed at 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed AL amyloidosis

  • Persistent or recurrent disease after 1 course of prior high-dose chemotherapy
• Previously treated with autologous stem cell transplantation

• Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following:

  • Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis)
  • Greater than 50% reduction in proteinuria with preservation of creatinine clearance
  • Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam
  • Subjective neurologic improvement, as confirmed by neurologist
  • Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass
  • Improvement in performance status* NOTE: *This criteria alone does not constitute significant improvement in organ function
• No myelodysplastic syndromes
• No abnormal bone marrow cytogenetics
• Prior stem cell yield must have been ≥ 2 x 10^6 CD34+ cells/kg

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• SWOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• See Disease Characteristics

Hepatic

• See Disease Characteristics

Renal

• See Disease Characteristics

Cardiovascular

• See Disease Characteristics
• LVEF ≥ 45% by MUGA or echocardiogram

Pulmonary

• DLCO ≥ 50%

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Acceptable toxicity from first transplantation, confirmed by the transplant team
• HIV negative
• No other concurrent malignancy except treated skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics
• No chemotherapy after first transplantation

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified