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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00564889 |
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Date of registration:
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28/11/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
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Scientific title:
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A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00564889 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig B. Reeder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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Vivek Roy, MD, FACP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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Shaji K. Kumar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histochemical diagnosis of AL amyloidosis based on detection of green birefringent
material in Congo red-stained tissue specimens by polarizing microscopy
- Measurable disease, as defined by one of the following:
- Serum monoclonal protein = 1.0 g by serum electrophoresis
- Urine monoclonal protein > 200 mg by 24-hour urine electrophoresis
- Serum immunoglobulin free light chain = 10 mg/dL AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio
- Symptomatic organ involvement with amyloid to justify therapy
- May include liver involvement, cardiac involvement, renal involvement, grade 1
peripheral neuropathy, or soft tissue involvement
- Must have more than skin purpura or carpal tunnel syndrome
- No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only
evidence of disease
- Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not
indicative of systemic amyloidosis
- No clinically overt multiple myeloma (i.e., monoclonal BMPC > 30%, bone lesions, or
hypercalcemia)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC = 1,000/µL
- Platelet count = 75,000/µL
- Creatinine < 3.0 mg/dL
- Not pregnant
- Negative pregnancy test
- Fertile patients must use two acceptable methods of contraception for = 28 days prior
to, during, and for = 28 days after completion of study treatment
- No nursing during and for = 28 days after completion of study treatment
- No blood, semen, or sperm donation during and for = 28 days after completion of study
treatment
- No malignancies within the past 5 years except treated basal cell or squamous cell
carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
- No neuropathy = grade 2, defined as motor neuropathy (symptomatic weakness interfering
with function, but not interfering with activities of daily living [ADL]) or sensory
neuropathy (sensory alteration or paresthesia [including tingling], interfering with
function, but not interfering with ADL)
- No uncontrolled infection
- No syncope within the past 30 days
- No known hypersensitivity to thalidomide, including desquamating rash with thalidomide
in the past
- No known seropositivity for HIV
- No active hepatitis A, B, or C
- No New York Heart Association class III or IV heart disease
- No venous thromboembolic event within the past 42 days
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation - Patients
intolerant to aspirin may use low molecular weight heparin
PRIOR CONCURRENT THERAPY:
- No prior lenalidomide
- More than 2 weeks since prior and no other concurrent anticancer agents or treatments
- More than 4 weeks since prior experimental agents
- No other concurrent corticosteroids except chronic steroids (maximum dose 20 mg/day of
prednisone equivalent) for disorders other than amyloidosis (e.g., adrenal
insufficiency or rheumatoid arthritis)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma and Plasma Cell Neoplasm
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Intervention(s)
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Drug: lenalidomide
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Drug: dexamethasone
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Drug: cyclophosphamide
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Primary Outcome(s)
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Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
[Time Frame: Duration on study (up to 3 years)]
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Secondary Outcome(s)
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Number of Participants With Severe Adverse Events
[Time Frame: Duration of study (up to 3 years)]
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Progression Free Survival (PFS)
[Time Frame: Duration of study (up to 3 years)]
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Number of Patients With Organ Response
[Time Frame: Duration of study (up to 3 years)]
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Overall Survival (OS)
[Time Frame: Duration of study (up to 3 years)]
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Secondary ID(s)
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06-005711
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P30CA015083
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NCI-2010-01954
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MC0685
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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