Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02302469
Eligibility Criteria:
Inclusion Criteria:
The most important criteria for patient eligibility include:
1. Age \>=18 years
2. Patients must have received prior therapy (any number of therapies) for WM and have relapsed or refractory WM
3. Eastern Cooperative Oncology Group performance score of 0 - 2
4. Hemoglobin \>= 10g/dL or hematocrit \>= 30%
5. Absolute neutrophil count (ANC) \>1000/mm3 and platelet count \>75,000/mm3
6. Adequate organ function defined as
* serum glutamate pyruvate transaminase and serum glutamate oxaloacetate transaminase \< 2 x International Unit/l
* Total bilirubin \>= 1.5 mg/dL
* Clearance creatinin \> 50 ml/mn
7. Evaluable immunochemical abnormalities including abnormal electrophoresis and serum free light chain assay with an increase of either kappa or lambda light chain lev -
Exclusion Criteria:
Key Exclusion criteria
1. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
2. Patients treated or requiring corticosteroids \>30mg/day
3. Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide)
4. Use of any other experimental drug or therapy within 28 days of baseline
5. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
6. Known positive for HIV or infectious hepatitis, type A, B or C -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02302469
Study Brief:
Protocol Section:
NCT02302469