Status:
COMPLETED
Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Celgene Corporation
Conditions:
Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be sto...
Detailed Description
This study will include previously treated patients with AL amyloidosis. Primary objectives to determine the hematologic and organ response rate to the association of cyclophosphamide, lenalidomide a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of AL amyloidosis.
- Evidence of a monoclonal light chain at serum and/or urine immunofixation electrophoresis.
- Elevated circulating free light chain (of the type identified by immunofixation) above the upper limit of the normal range and abnormal kappa/lambda ratio.
- Previously treated and requiring further treatment.
- Symptomatic organ involvement.
- Bone marrow plasma cell \<30%.
- Echocardiographic ejection fraction \>40%.
- Troponin I \<0.1 ng/mL.
- Hemoglobin \>10 g/dL.
- Absolute neutrophil count \>1500/uL.
- Platelet count \>140000/uL.
- Total bilirubin \<2.5 mg/dL.
- Alkaline phosphatase \<4 x upper reference limit (u.r.l.).
- ALT \<3 x u.r.l..
- Glomerular filtration rate \>30 mL/min.
- Performance status ECOG 1-3.
- Female subjects of childbearing potential must have two negative pregnancy tests prior to starting study drug.
- Exclusion Criteria:
- Prior treatment with the association of cyclophosphamide, lenalidomide and dexamethasone or with lenalidomide.
- Requirement for other concomitant chemotherapy, immunotherapy or radiotherapy, or any investigational ancillary therapy.
- Presence of other active malignancies, with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limits.
- Clinically overt multiple myeloma.
- Uncontrolled infection.
- New York Heart Association (NYHA) class 4 heart failure.
- Enzyme documented myocardial infarction within 6 months before enrollment.
- Grade 2 or 3 atrioventricular block (Mobitz type I is permitted).
- Repetitive ventricular arrhythmias at 24 h Holter electrocardiogram in spite of treatment with amiodarone.
- Supine systolic blood pressure \<90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of \>20 mmHg in spite of being treated for orthostatic hypotension.
- Prior history of thrombosis or venous thromboembolism or pulmonary embolism. Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.
- Indication to receive clopidogrel, ticlopidine or warfarin.
- Factor X level \<20%.
- Poorly controlled diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months).
- Previous or ongoing psychiatric illness (with the exclusion of reactive depression).
- Pregnant or nursing women.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00607581
Start Date
February 1 2008
End Date
January 1 2012
Last Update
February 10 2012
Active Locations (1)
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1
Amyloidosis Research and Treatment Center - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100