AL-amyloidose
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
Product Name: Bendamustine
Pharmaceutical Form: Intravenous infusion
Sponsors
Klinik f. Innere Med., Fachabteilung Hämatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of lenalidomide, bendamustine and dexamethasone to induce objective responses in patients with AL-amyloidosis.;Secondary Objective: • To determine the optimal dosage of the combination of lenalidomide, bendamustine and dexamethasone in patients with AL-amyloidosis. • To evaluate the safety of the combination therapy.;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed