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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.
Last refreshed on: 19 October 2017
Main ID:  NCT00458822
Date of registration: 09/04/2007
Prospective Registration: Yes
Primary sponsor: Memorial Sloan Kettering Cancer Center
Public title: Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis
Scientific title: Risk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) Amyloidosis
Date of first enrolment: February 2007
Target sample size: 40
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Name:     Heather Landau, MD
Affiliation:  Memorial Sloan Kettering Cancer Center
Key inclusion & exclusion criteria


- Histologically confirmed amyloidosis

- Diagnosed within the past 12 months

- Clonal plasma cell disorder, as demonstrated by any of the following:

- Presence of M-protein in serum and/or urine by immunofixation and/or serum
free light chain assay

- Clonal population of plasma cells in the bone marrow based on kappa/lambda
staining of a marrow biopsy

- Negative genetic testing for hereditary forms of amyloidosis

- No amyloid-specific syndrome (e.g., carpal tunnel syndrome or skin purpura) as the
only evidence of disease

- Vascular amyloidosis only in a bone marrow biopsy specimen or in plasmacytoma is
not indicative of systemic amyloidosis

- No advanced cardiac amyloidosis

- Must have symptomatic involvement of no more than 2 of the following visceral organ

- Kidneys

- Liver/gastrointestinal

- Peripheral/autonomic nervous system

- Heart

- No persistent pleural effusions

- No clinically overt multiple myeloma with > 30% plasma cells in the bone marrow or
lytic bone lesions

- Able to undergo autologous stem cell transplantation


- SWOG performance status 0-3

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Bilirubin < 2.0 mg/dL

- Creatinine clearance < 51 mL/min allowed

- LVEF > 45% by echocardiogram

- No New York Heart Association class III-IV congestive heart failure

- No history of cardiac syncope

- No recurrent symptomatic arrhythmias

- No oxygen-dependent restrictive cardiomyopathy

- No myocardial infarction within the past 6 months

- Pulmonary diffusion capacity > 50% predicted by pulmonary function testing

- No uncontrolled infection

- No other active malignancy, except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I cancer from which the patient is currently in complete

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

- No hypersensitivity to bortezomib, boron, or mannitol

- No HIV positivity

- No serious medical or psychiatric illness that would preclude study compliance


- At least 14 days since prior investigational drugs

- No prior therapy for monoclonal plasma disease

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
Drug: dexamethasone
Primary Outcome(s)
Hematologic and Organ Response [Time Frame: 2-3 months post transplant]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results available: Yes
Date Posted: 10/08/2016
Date Completed:
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