A phase I-II trial of lenalidomide, bendamustin and dexamethasone in the treatment of patients with systemic AL-amyloidosis and ineligible for stem cell transplantation - LeBenD
- Conditions
- AL-amyloidose
- Registration Number
- EUCTR2008-007125-39-AT
- Lead Sponsor
- Klinik f. Innere Med., Fachabteilung Hämatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
• Symptomatic primary systemic amyloidosis based on both: a tissue diagnosis of amyloidosis based on polarizing microscopy of green birefringent material in Congo red–stained tissue specimens and immunohistochemical stains of that tissue demonstrating monoclonal light chain deposition
• Patient is not eligible for autologous stem cell transplantation
• Age >18 years
• Blood haemoglobin > 8g/dl
• Platelets >60 x 109/l
• WBC > 2,0 x 109/l
• ANC > 1 x 109/l
• Glomerular Filtration Rate >30ml/min
• ECOG Performance Status of 0, 1 or 2
• Patient’s written informed consent
• Patient is able to take aspirin (100 mg) daily as prophylactic anticoagulation
• Women of child-bearing potential must have a negative pregnancy test
• Effective contraception for both men and women of child bearing
potential for the entire treatment period
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
• Patient is eligible for autologous stem cell transplantation
• Patient with end-stage renal failure or on dialysis
• Pregnant or breast feeding women
• Men and women of childbearing potential who are unwilling to use an effective method of contraception for the entire treatment period
• Deep-vein thrombosis or pulmonary embolism at entry of study
• Previous treatment for AL-amyloidosis within 4 weeks of study entry with chemotherapy
• Previous treatment with lenalidomide or bendamustine
• Known intolerance to lenalidomide, bendamustine or dexamethasone
• Use of any investigational agent within 28 days prior to screening
• History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method