amyloidosis AL MedDRA version: 6.1 Level: PT Classification code 10002022
Conditions
Interventions
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: Table
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion 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 /=40%. Troponin I /=10 g/dL.Absolute neutrophil count >1500/mcL.Platelet count >/=140000/mcL.Total bilirubin 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.to determine the safety of CLD, 2.to determine the hematologic and organ response rate to CLD.;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;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. | — |
Countries
Italy
Outcome results
None listed