An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex

OSPEDALE POLICLINICO S. MATTEO0 个研究点开始时间: 2012年1月12日最近更新: 2012年10月2日

适应症

试验速览

暂无简介。

•At least 18 years. • Diagnosis of systemic AL amyloidosis. Symptomatic organ involvement. • Patients achieving less than complete response after initial treatment with an alkylating agent and bortezomib. Patients with AL amyloidosis who received 1 previous treatment, but who could not be treated with alkylators and/or bortezomib due to contraindications, will be eligible. • Measurable disease: difference between amyloidogenic (involved) and uninvolved free light chains (dFLC) >50 mg/L. • Hb =10 g/dL • ANC =1500/mcL. • Platelet count =100000/mcL. • eGFR =30 mL/min per 1.73 m2. • Performance status (ECOG) <3. • Total bilirubin <2.5 mg/dL. • Alkaline phosphatase <5 × url. • ALT <3 × url. Subjects must be informed about pregnancy program prevention
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 19
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 9

•Amyloid-specific syndrome • New York Heart association (NYHA) class IV. • Known positivity for HIV or active hepatitis infection. • Pregnant or nursing women (men must agree to use an acceptable method for contraception for the duration of the study). • Uncontrolled infections. • Other active malignancies. • Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism. • Known hypersensitivity to thalidomide or lenalidomide including development of erythema. • Previous or ongoing psychiatric illness (with the exclusion of reactive depression).

发起方

OSPEDALE POLICLINICO S. MATTEO