High-Dose Melphalan Followed by Peripheral Stem Cell Transplant in Treating Patients With Amyloidosis

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.

PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.

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

Details

• Lead Sponsor: Temple University
• Treatments: Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of abdominal fat, bone marrow, or other target tissues

• Pathology reviewed by Temple University

• Amyloidosis secondary to any stage of multiple myeloma allowed provided plasma cell concentration in bone marrow is less than 15%

• No amyloidosis secondary to rheumatoid arthritis or chronic infection

• No familial amyloidosis

PATIENT CHARACTERISTICS:

Age:

• 16 to 65

Performance status:

• Karnofsky 80-100%

Hematopoietic:

• Not specified

Hepatic:

• Liver function tests less than twice normal

• No active liver disease

Renal:

• Creatinine clearance greater than 50 mL/min

• Nephrotic syndrome allowed

Cardiovascular:

• Cardiac evaluation required in patients with left ventricular ejection fraction less than 45% by echocardiogram or MUGA

• No poorly controlled hypertension

Pulmonary:

• FEV_1 and DLCO greater than 50% of predicted, or pulmonary evaluation required

• No chronic obstructive pulmonary disease

Other:

• No history of serious coagulopathy, hemorrhage, or bleeding

• No active infection

• No other serious comorbid disease (e.g., poorly controlled diabetes)

• No pregnant women

• Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 12 monthly cycles of prior alkylating agent chemotherapy discouraged

Endocrine therapy:

• Corticosteroids discontinued at least 6 weeks prior to transplantation

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified