Overview

High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow. Peripheral stem cell transplantation PURPOSE: Phase II trial to study the effectiveness of high dose melphalan plus peripheral stem cell transplantation in treating patients who have primary systemic amyloidosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Melphalan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary amyloidosis Must have presence of
paraprotein in serum or urine determined by immunoelectrophoresis/immunofixation No primary
amyloidosis manifested only by carpal tunnel syndrome or purpura No history of secondary,
familial, or localized amyloidosis No evidence of overt multiple myeloma: Lytic bone
disease or pathological fractures OR At least 30% plasma cells in bone marrow

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute granulocyte count at least 1000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no
greater than 1000 u/L or less than 4 times upper limit of normal Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: Confirmed by echocardiogram: Ejection fraction at
least 50% Interventricular septal thickness no greater than 15 mm No New York Heart
Association classification II-IV Pulmonary: DLCO at least 50% FVC at least 60% FEV1 at
least 55% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No active infection No other malignancy within the past 5 years
except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or
indolent prostate cancer No known sensitivity to E. coli derivatives

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon allowed Chemotherapy: At least
4 weeks since prior melphalan Lifetime cumulative dose of melphalan no greater than 150 mg
No greater than 2 prior courses of chemotherapy Endocrine therapy: Prior dexamethasone
allowed Radiotherapy: Not specified Surgery: Not specified