Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatments
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Capsule*
Trade Name: Endoxan
Pharmaceutical Form: Tablet
Trade Name: Dexamethasone
Pharmaceutical Form: Tablet
Trade Name: REVLIMID
Pharmaceutical Form: Ca
Sponsors
Hellenic Oncology Cooperative Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age >18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Confirmed diagnosis of AL amyloidosis 5. Need for treatment in the judgment of their treating physician 6. Evaluable or measurable disease defined by any of the following: I. Measurable serum free light chains > 10 mg/dL, kappa or lambda, provided ?/? ratio is abnormal (measurable disease) or abnormal ?/? ratio (evaluable) II. monoclonal protein in the serum>1 g/dL 7. ECOG Performance Status (PS) 0, 1, 2 or 3 8. Laboratory test results within these ranges: • Absolute neutrophil count >=1.0 x 109/L • Platelet count >= 100 x 109/L • Serum creatinine 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “insitu” of the cervix or breast 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin). 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: 1. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis 2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Known hypersensitivity to thalidomide. 7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 8. Any prior use of lenalidomide. 9. Concurrent use of other anti-cancer agents or treatments. 10. Known positive for HIV or infectious hepatitis, type A, B or C. 11. >grade 2 peripheral neuropathy 12. Life expectancy < 3 months 13. Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis. • To assess organ response rate of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis. ;Primary end point(s): • Hematologic and organ progression free survival ;Main Objective: • To assess the maximum tolerated dose of lenalidomide in combination with Cyclophosphamide and Dexamethasone in patients with AL amyloidosis. • To assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis | — |
Countries
Greece
Outcome results
None listed