An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND

• Conditions: amyloidosis AL; MedDRA version: 6.1Level: PTClassification code 10002022

• Registration Number: EUCTR2007-006037-13-IT
• Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified