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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:  NCT00520767
Date of registration: 24/08/2007
Prospective Registration: Yes
Primary sponsor: Barbara Ann Karmanos Cancer Institute
Public title: Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
Scientific title: A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease
Date of first enrolment: September 2007
Target sample size: 35
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT00520767
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:     Jeffrey A. Zonder, MD
Address: 
Telephone:
Email:
Affiliation:  Barbara Ann Karmanos Cancer Institute
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Biopsy-proven diagnosis of 1 of the following:

- Primary systemic amyloidosis

- Histochemical diagnosis of amyloidosis determined by polarizing microscopy
of green bi-refringent material in Congo red-stained tissue specimens or
characteristic electron microscopy appearance

- Light chain deposition disease

- Measurable disease as defined by one or more of the following:

- Serum monoclonal protein = 0.5 g/dL by serum electrophoresis

- Urine monoclonal protein > 200 mg/tv in a 24 hr urine electrophoresis

- Serum immunoglobulin free-light chain = 10 mg/dL AND abnormal serum
immunoglobulin kappa lambda free light chain ratio

- Must meet 1 of the following criteria:

- Clonal population of plasma cells in the bone marrow (= 30%)

- Immunohistochemical stain with anti-light chain anti-sera of amyloid fibrils

- Must not meet the following diagnostic criteria for symptomatic* multiple myeloma:

- Lytic lesions on skeletal survey

- Plasmacytoma

- Increase in bone marrow plasma cells = 30% NOTE: *Patients who meet the
International Myeloma Working Group definition of symptomatic multiple myeloma
with symptoms attributable only to associated amyloidosis and who do not
otherwise meet the criteria for diagnosis of smoldering myeloma are potentially
eligible upon approval of the principal investigator.

- If not previously treated, patient is either not a candidate for autologous stem cell
transplantation (ASCT) or has declined the option of ASCT

- Patients who have undergone prior ASCT and have subsequently progressed are
eligible, provided other eligibility criteria are met

- No secondary or familial amyloidosis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Creatinine < 5 mg/dL

- Bilirubin < 2.5 times upper limit of normal (ULN)

- ALT and AST < 3 times ULN

- Absolute neutrophil count = 1,000/mm³

- Platelet count = 80,000/mm³

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Peripheral sensory neuropathy < grade 3

- No myocardial infarction within the past 6 months

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

- No uncontrolled angina

- No severe uncontrolled ventricular arrhythmias

- No EKG* evidence of acute ischemia or active conduction system abnormalities (not
including 1st degree AV-block, Wenckebach type 2nd degree heart block, or left bundle
branch block) NOTE: *Prior to study entry, any EKG screening abnormality must be
documented by the investigator as not medically relevant; there is no lower limit of
LVEF below which patients are excluded from participation

- No hypersensitivity to bortezomib, boron, or any of the other agents utilized in this
study

- No serious concurrent illness (e.g., stroke) within the past 30 days

- No psychiatric illness likely to interfere with study participation

- No untreated HIV infection

- Patients with asymptomatic HIV infection on active antiretroviral therapy are
potentially eligible

- No diagnosis or treatment of another malignancy within the past 3 years, except
completely resected basal cell or squamous cell carcinoma of the skin, an in situ
malignancy, or low-risk prostate cancer after curative therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No other investigational drugs within the past 14 days



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All
Health Condition(s) or Problem(s) studied
Light Chain Deposition Disease
Primary Systemic Amyloidosis
Intervention(s)
Drug: bortezomib
Drug: dexamethasone
Drug: melphalan
Genetic: microarray analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Primary Outcome(s)
Complete Hematologic Response [Time Frame: Up to 12 months]
Secondary Outcome(s)
Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire. [Time Frame: At the start of each cycle]
Organ Response Rate (OrR) [Time Frame: Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.]
Overall Hematologic Response Rate (OHR) [Time Frame: Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.]
Overall Survival [Time Frame: Day 1 of Each Cycle and every 12 weeks after last treatment cycle]
Time to Treatment Failure [Time Frame: Day 1 of Each Cycle]
Toxicity, Including Neurotoxicity [Time Frame: Day 1 of Each Cycle]
Secondary ID(s)
CDR0000555016
MILLENNIUM-WSU-2006-132
P30CA022453
WSU-2006-132
WSU-HIC-060907M1F
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available: Yes
Date Posted: 30/03/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00520767
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