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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00003353
Date of registration: 01/11/1999
Prospective Registration: No
Primary sponsor: Eastern Cooperative Oncology Group
Public title: High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis
Scientific title: A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
Date of first enrolment: July 1998
Target sample size:
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00003353
Study type:  Interventional
Study design:  Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Morie A. Gertz, MD
Address: 
Telephone:
Email:
Affiliation:  Mayo Clinic
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Myeloma and Plasma Cell Neoplasm
Intervention(s)
Biological: filgrastim
Drug: melphalan
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
CDR0000066334
E-4A97
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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