Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.
- Conditions
- Previously treated AL amyloidosisMedDRA version: 14.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001787-22-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of pomalidomide + dexamethasone (PDex) in patients who did not achieve a complete response after initial treatment with both an alkylating agent and bortezomib.;Secondary Objective: To assess the safety of PDex combination. To assess the survival of AL Amyloidosis patients treated with PDex.;Primary end point(s): To assess the rate of hematologic response at 3 months;Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Rate of adverse events. Rate of complete response at 3, 6, 9, and 12 months. Hematologic response rate at 6, 9, and 12 months. Organ response rate at 3, 6, 9, and 12 months. Progression-free survival. Overall survival.;Timepoint(s) of evaluation of this end point: See secondary endpoints