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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:  NCT00052884
Date of registration: 24/01/2003
Prospective Registration: Yes
Primary sponsor: Eastern Cooperative Oncology Group
Public title: Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Scientific title: A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
Date of first enrolment: October 2003
Target sample size: 8
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00052884
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
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 amyloidosis

- No secondary familial or localized amyloidosis

- Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or
urine

- No primary amyloidosis manifested only by carpal tunnel syndrome or purpura

- Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic
individual not considered an amyloid syndrome

- Amyloid syndromes include any of the following:

- Hepatomegaly

- Cardiomyopathy

- Nephrotic range proteinuria

- Peripheral or autonomic neuropathy

- No multiple myeloma defined by 1 of the following:

- Presence of lytic bone disease

- More than 30% bone marrow plasma cells

PATIENT CHARACTERISTICS:

Age

- 18 to 70

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Platelet count at least 100,000/mm^3

Hepatic

- See Disease Characteristics

- Total or direct bilirubin no greater than 2.0 mg/dL

- Alkaline phosphatase no greater than 4 times upper limit of normal

Renal

- See Disease Characteristics

- Creatinine less than 3.0 mg/dL

Cardiovascular

- See Disease Characteristics

- Ejection fraction at least 45% by echocardiogram

- No New York Heart Association class III or IV heart disease

- Systolic blood pressure = 90 mmHg

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior interferon

Chemotherapy

- At least 4 weeks since prior melphalan

- Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)

Endocrine therapy

- At least 4 weeks since prior dexamethasone

Radiotherapy

- No prior radiotherapy for amyloidosis

Surgery

- Not specified

Other

- No antihypertensive medications for at least 24 hours prior to, during, and for 1
hour after amifostine administration

- No other prior treatment



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Drug/Agent Toxicity by Tissue/Organ
Multiple Myeloma and Plasma Cell Neoplasm
Intervention(s)
Biological: filgrastim
Drug: amifostine trihydrate
Drug: melphalan
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Primary Outcome(s)
Maximum Tolerated Dose [Time Frame: Assessed over 30 days]
Secondary Outcome(s)
Secondary ID(s)
CDR0000258785
ECOG-E2A01
U10CA021115
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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