Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
NCT ID: NCT00520767
Last Updated: 2023-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2007-09-30
2019-06-06
Brief Summary
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PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.
Detailed Description
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Primary
* Determine the complete hematologic response rate at 12 months.
Secondary
* Determine the overall hematologic response rate.
* Determine the organ response rate.
* Determine time to treatment failure.
* Determine the overall survival.
OUTLINE: This is a multicenter study.
Patients receive oral melphalan on days 1-4, bortezomib IV on days 1, 8, 15, and 22, and dexamethasone orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 4-6 weeks for up to 20 courses in the absence of disease progression or unacceptable toxicity.
Blood, urine, and bone marrow aspirates are collected at baseline and periodically after treatment to permit the correlation of clinical results with measured molecular events. A single baseline peripheral blood DNA sample is collected for future association studies linking disease onset, progression, and response to administered therapy with single nucleotide polymorphisms. Blood plasma and urine samples are evaluated for proteomic markers associated with disease progression and therapeutic response. Peripheral blood RNA samples are evaluated for transcriptional response to treatment of peripheral blood lymphocytes. Bone marrow aspirates are collected to extract plasma cells by flow cytometry for gene expression profiling.
Quality of life is assessed at the beginning of each course.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Melphalan, Dexamethasone, Bortezomib,
Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
bortezomib
Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone
Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan
Melphalan 9 mg/m2/day days 1-4
microarray analysis
≤28 days prior to enrollment
flow cytometry
Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis
≤28 days prior to enrollment
quality-of-life assessment
Start of each cycle
Interventions
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bortezomib
Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone
Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan
Melphalan 9 mg/m2/day days 1-4
microarray analysis
≤28 days prior to enrollment
flow cytometry
Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis
≤28 days prior to enrollment
quality-of-life assessment
Start of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Jeffrey Zonder
Principal Investigator
Principal Investigators
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Jeffrey A. Zonder, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Rocky Mountain Cancer Centers/Rocky Mountain Blood & Marrow Transplant Program
Denver, Colorado, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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MILLENNIUM-WSU-2006-132
Identifier Type: -
Identifier Source: secondary_id
WSU-HIC-060907M1F
Identifier Type: OTHER
Identifier Source: secondary_id
2006-132
Identifier Type: -
Identifier Source: org_study_id