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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00075621 |
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Date of registration:
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09/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
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Scientific title:
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A Phase II Trial of Tandem Transplantation in AL Amyloidosis |
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Date of first enrolment:
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August 2000 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00075621 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Vaishali Sanchorawala, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
- Plasma cell dyscrasia, evidenced by 1 of the following:
- Monoclonal protein in the serum or urine by immunofixation electrophoresis
- Plasmacytosis of the bone marrow with monoclonal staining for kappa or
lambda light chain isotype
- Macroglossia with at least 1 other site having biopsy proven amyloidosis and
absence of a mutant transthyretin is ruled out
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- SWOG 0-2
Life expectancy
- At least 1 year
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- LVEF = 45% by MUGA or echocardiogram
Pulmonary
- DLCO = 50%
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to tolerate 2 courses of high-dose therapy
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior alkylating agent chemotherapy allowed provided there is no morphologic or
cytogenetic evidence of myelodysplastic syndromes
- Prior total cumulative oral melphalan dose < 300 mg
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4 weeks since prior cytotoxic therapy and recovered
Exclusion Criteria:
- No senile, secondary, localized, dialysis-related, or familial amyloidosis
- No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive
[more than 2] lytic lesions, hypercalcemia)
Cardiovascular
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No arrhythmia refractory to therapy
- No evidence of symptomatic transient ischemic attacks or strokes
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: filgrastim
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Procedure: autologous peripheral blood stem cell transplantation
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Drug: melphalan
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Primary Outcome(s)
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safety
[Time Frame: 100 days, 6 months, and annual]
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Secondary Outcome(s)
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Efficacy
[Time Frame: one year]
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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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