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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: 16 December 2017
Main ID:  NCT00890552
Date of registration: 28/04/2009
Prospective Registration: Yes
Primary sponsor: Stanford University
Public title: A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
Scientific title: A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
Date of first enrolment: April 2009
Target sample size: 25
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00890552
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Stanley L Schrier, MD
Address: 
Telephone:
Email:
Affiliation:  Stanford University
Key inclusion & exclusion criteria

INCLUSION CRITERIA

- Newly diagnosed or relapsed AL amyloidosis

- Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia

- abnormal clonal dominance of plasma cells in the bone marrow

- detection of a monoclonal gammopathy by immunofixation electrophoresis of serum
and/or urine

- an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy)

- Measurable disease defined by an abnormal serum-free light chain or monoclonal protein
by immunofixation

- proteinuria = 0.5 g/day, cardiac involvement with interventricular septal
thickness = 15 mm

- hepatomegaly in the absence of congestive heart failure with elevated alkaline
phosphatase

- Age = 18 years at the time of signing the informed consent form.

- All previous cancer therapy must have been discontinued at least 4 weeks prior to
treatment in this study

- ECOG performance status of = 3 at study entry

- Laboratory test results:

- Absolute neutrophil count = 1.0 x 10e9 / L

- Platelet count = 75 x 10e9 / L

- Creatinine clearance = 15 mL/ minute

- Total bilirubin = 2-fold upper limits of normal

- Disease-free of prior malignancies (excluding multiple myeloma) for = 3 years with
exception of:

- currently treated basal cell

- squamous cell carcinoma of the skin

- carcinoma "in situ" of the cervix or breast.

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test

- Females of childbearing potential must either:

- commit to continued abstinence from heterosexual intercourse

- acceptable methods of birth control and agree to ongoing pregnancy testing

- Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy

- All study participants must be registered into the mandatory RevAssist program, and
able to comply with its requirements

- Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed
consent form

- Able to adhere to the study visit schedule and other protocol requirements

EXCLUSION CRITERIA

- Any serious medical condition that would prevent the subject from signing the informed
consent form

- Pregnant

- breast-feeding females

- Use of any other experimental drug or therapy within 28 days of baseline

- Known hypersensitivity to thalidomide

- Erythema nodosum if characterized by a desquamating rash while taking thalidomide or
similar drugs

- Any prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- Known positivity for human immunodeficiency virus HIV)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Amyloidosis
Leukemia
Intervention(s)
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Melphalan
Primary Outcome(s)
Hematologic Response Rate [Time Frame: 8 weeks]
Secondary Outcome(s)
Duration of Response [Time Frame: 32 months]
Event-free Survival (EFS) [Time Frame: 12 months]
Overall Survival (OS) [Time Frame: 12 months]
Secondary ID(s)
HEM0010
IRB-15213
RV-AMYL-PI-0375
SU-09192008-1300
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Celgene Corporation
Ethics review
Results
Results available: Yes
Date Posted: 22/03/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00890552
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