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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: EUCTR
Last refreshed on: 26 June 2012
Main ID:  EUCTR2007-006037-13-IT
Date of registration: 10/12/2007
Prospective Registration: Yes
Primary sponsor: OSPEDALE POLICLINICO S. MATTEO
Public title: An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND
Scientific title: An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND
Date of first enrolment: 21/02/2008
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006037-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Italy
Contacts
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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.Age >/=18 years.Must have been previously treated (failed at least 1 previous treatment for AL amyloidosis) and in the opinion of the investigator requires further treatment.Symptomatic organ (heart, kidney, liver, peripheral nervous system or soft tissue) involvement.Bone marrow plasma cell <30% in bone marrow aspirate. Echocardiographic ejection fraction >/=40%. Troponin I <0.1 ng/mL.Hemoglobin >/=10 g/dL.Absolute neutrophil count >1500/mcL.Platelet count >/=140000/mcL.Total bilirubin <2.5 mg/dL.Alkaline phosphatase <4 x upper reference limit (u.r.l.). ALT 30 mL/min x 1.73 m2 (according to MDRD). Female subjects of childbearing potential (FCBP) must have two negative pregnancy tests prior to starting study drug.Male: Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Prior treatment with CTD or 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.Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.Patient has a prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.Patient has a clear indication to receive clopidogrel, ticlopidine or warfarin.Factor X level <20%.Stool guaiac tests result positive (1 of 3); further diagnostic workup for a bleeding source should be performed and the subject reevaluated for study entry.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:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
amyloidosis AL
MedDRA version: 6.1 Level: PT Classification code 10002022
Intervention(s)

Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Pharmaceutical Form: Oral solution
INN or Proposed INN: Dexamethasone
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: 1.to determine the safety of CLD, 2.to determine the hematologic and organ response rate to CLD.
Primary end point(s): 1. frequency, type, severity of adverse events and their relationship to therapy, 2. rate of hematologic and organ response as determined by the International Society for Amyloidosis criteria (Sections 7.1 and 7.2) calculated on an intent-to-treat basis.
Secondary Objective: 1.to determine time to response to CLD, 2.to determine the duration of response to CLD, 3.to assess survival of AL amyloidosis patients treated with CLD
Secondary Outcome(s)
Secondary ID(s)
AC-003-IT
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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