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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT01199718
Eligibility Criteria:
Inclusion Criteria:
* Males or females at least 18 years of age
* Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
* Measureable disease.
* Karnofsky Performance Status at least 60%
* Adequate liver and renal function and hematology laboratory values
* Female patients of child-bearing potential must have a negative pregnancy test.
* Signed informed consent.
Exclusion Criteria:
* Treatment with systemic cancer therapy within 21 days before screening.
* Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
* Grade 3 sensory neuropathy or motor neuropathy with pain
* Concurrent severe or uncontrolled medical disease.
* Active systemic fungal, bacterial, and/or viral infection.
* Difficulty with swallowing, or an active malabsorption syndrome.
* Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.
* History of gastric or small bowel surgery.
* Pregnant or nursing females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01199718
Study Brief:
Protocol Section:
NCT01199718