World Health Organization site
Skip Navigation Links

Main
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 October 2017
Main ID:  NCT00790647
Date of registration: 12/11/2008
Prospective Registration: Yes
Primary sponsor: Boston Medical Center
Public title: Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Scientific title: Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis
Date of first enrolment: June 2008
Target sample size: 10
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00790647
Study type:  Interventional
Study design:   
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 primary systemic amyloidosis based on the following criteria:

- Amyloid light-chain disease

- Deposition of amyloid material by congo red stain showing characteristic green
birefringence

- Monoclonal light chain protein (Bence Jones protein) in the serum or urine,
immunohistochemical studies, or serum free light chain assay

- Evidence of tissue involvement other than carpal tunnel syndrome (i.e., positive
immunohistochemical staining of bone marrow demonstrating clonal plasma cells);
tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a
plasma cell dyscrasia by serum/urine or bone marrow; or overwhelmingly convincing
clinical features (e.g., macroglossia) associated with other systemic
manifestations

PATIENT CHARACTERISTICS:

- Southwest Oncology Group performance status 0-1

- Fertile patients must use effective contraception

- Left ventricular ejection fraction = 45% by Echocardiogram within the past 60 days

- diffusion capacity of lung for carbon monoxide = 50%

PRIOR CONCURRENT THERAPY:

- Prior chemotherapy with alkylating agent allowed provided there is no morphological or
cytogenetic evidence of myelodysplastic syndromes

- Prior total cumulative dose of oral melphalan < 300 mg

- At least 4 weeks since prior cytotoxic therapy and fully recovered

Exclusion criteria:

- No senile, secondary, localized, dialysis-related, or familial amyloidosis

- No overt multiple myeloma (> 30% of bone marrow plasmacytosis, extensive [> 2] lytic
lesions, or hypercalcemia)

- Not pregnant or nursing

- No myocardial infarction within the past 6 months, congestive heart failure, or
arrhythmia refractory to therapy

- No prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer currently in complete remission

- Any cancer from which the patient has been disease-free = 5 years

- No advanced (grade 3-4) pre-existing neuropathy

- No HIV positivity



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Myeloma
Intervention(s)
Biological: filgrastim
Drug: bortezomib
Drug: melphalan
Procedure: Stem Cell Infusion
Primary Outcome(s)
Number of Participants With Hematologic Response [Time Frame: one year]
Secondary Outcome(s)
Number of Participants Surviving at 1 Year [Time Frame: one year from transplant]
Number of Participants Surviving at 100 Days From Transplant [Time Frame: 100 Days from transplant date]
Number of Participants Surviving at 2 Years [Time Frame: 2 years from transplant]
Secondary ID(s)
BUMC-H-27277
CDR0000618857
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 06/02/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00790647
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history