Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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3 July 2023 |
Main ID: |
NCT00003353 |
Date of registration:
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01/11/1999 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis
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Scientific title:
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A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis |
Date of first enrolment:
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November 16, 1998 |
Target sample size:
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Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00003353 |
Study type:
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Interventional |
Study design:
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Primary purpose: Treatment.
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Morie A. Gertz, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma and Plasma Cell Neoplasm
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Intervention(s)
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Drug: melphalan
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Procedure: bone marrow ablation with stem cell support
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Procedure: peripheral blood stem cell transplantation
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Biological: filgrastim
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Secondary ID(s)
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CDR0000066334
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E-4A97
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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