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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00087867
Eligibility Criteria:
Inclusion Criteria:
* Life expectancy more than three months
* diagnosed with multiple myeloma (MM)
* relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
* Karnofsky performance status = 60
* no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
* no history of myocardial infarction within last 6 months
* serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
* total serum bilirubin = 2X ULN
* Calculated or measured creatinine clearance \>30 mL/min
* platelet count = 30 x 10(9)/L
* hemoglobin concentration = 8 g/dL
* white blood cell count = 2.0 x 10(9)/L
Exclusion Criteria:
* Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
* major surgery within four weeks of enrollment
* severe elevated serum calcium
* heart failure
* receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
* receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
* known allergies to agents used in bortezomib (e.g., boron or mannitol)
* poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00087867
Study Brief:
Protocol Section:
NCT00087867