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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: 19 February 2015
Main ID:  NCT00607581
Date of registration: 22/01/2008
Prospective Registration: Yes
Primary sponsor: IRCCS Policlinico S. Matteo
Public title: Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
Scientific title: An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
Date of first enrolment: February 2008
Target sample size: 21
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00607581
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Giampaolo Merlini, M.D.
Address: 
Telephone:
Email:
Affiliation:  Fondazione IRCCS Policlinico San Matteo
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Amyloidosis
Intervention(s)
Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide
Primary Outcome(s)
hematologic response rate [Time Frame: at 3 months]
Secondary Outcome(s)
organ response rate [Time Frame: at 3 months]
survival [Time Frame: up to 3 years after treatment discontinuation]
time to progression [Time Frame: every 3 months for 3 years]
time to response [Time Frame: every 28 days]
toxicity [Time Frame: continuous during treatment]
Secondary ID(s)
AC-003-IT
RV-AMYL-PI-303
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Celgene Corporation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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