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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: 12 December 2020
Main ID:  NCT00075621
Date of registration: 09/01/2004
Prospective Registration: No
Primary sponsor: Boston Medical Center
Public title: Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
Scientific title: A Phase II Trial of Tandem Transplantation in AL Amyloidosis
Date of first enrolment: August 2000
Target sample size: 62
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00075621
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Vaishali Sanchorawala, MD
Address: 
Telephone:
Email:
Affiliation:  Boston Medical Center
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Multiple Myeloma
Intervention(s)
Drug: filgrastim
Drug: melphalan
Procedure: autologous peripheral blood stem cell transplantation
Primary Outcome(s)
safety [Time Frame: 100 days, 6 months, and annual]
Secondary Outcome(s)
Efficacy [Time Frame: one year]
Secondary ID(s)
H-23645
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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