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:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02287558
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Transfusion of at least 4 units of blood and/or four doses of intravenous iron over the preceding four months.
3. Recurrent bleeding after at least one previous interventional endoscopic procedure
4. Platelet count ≥ 125,000/µl
5. WBC ≥ 4,000/µl
6. Normal prothrombin (PT) and activated partial thromboplastin time (aPTT)
7. Endoscopically-documented angiodysplasia and/or arteriovenous malformations involving the small bowel
8. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy.
9. Ability to understand and sign informed consent
10. All study participants must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program
Exclusion Criteria:
1. Pregnancy (must be excluded by two urine or serum tests for β-HCG in all women of child-bearing potential).
Pregnancy Testing -Must follow pregnancy testing requirements as outlined in the POMALYST REMS™ program.
2. Breast feeding
3. Renal insufficiency, serum creatinine \> 2.0 mg/dl
4. Hepatic insufficiency, bilirubin \> 2.0 or transaminases \> 3.0 x normal
5. Previous treatment with Thalidomide or other imid drugs within previous 12 months
6. History of prior thromboembolism with known thrombophilia
7. Peripheral neuropathy, as determined from neurologic consultation
8. Underlying hypoproliferative anemia (i.e. myelodysplasia)
9. Inherited or significant acquired coagulopathy (i.e. hemophilia, advanced liver disease)
10. Chronic aspirin, NSAID therapy, anticoagulation therapy or antiplatelet agents
11. Currently enrolled in other interventional trials
12. Known hypersensitivity to thalidomide or lenalidomide.
13. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, or similar drugs.
14. Anything that in the investigator's opinion is likely to interfere with completion of the study † A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02287558
Study Brief:
Protocol Section:
NCT02287558