Status:
COMPLETED
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
Detailed Description
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR t...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00890552
Start Date
April 1 2009
End Date
October 1 2012
Last Update
March 22 2017
Active Locations (1)
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1
Stanford University Cancer Institute
Stanford, California, United States, 94305