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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT02353468
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic active multiple myeloma who have completed autotransplant are eligible for the study; patients should be assessed for eligibility within 35 days of the transplant and treatment should commence within 10 weeks of the transplant
* Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients with a poor performance status (3-4) are also eligible, if complications of the bone such as compression fracture, hyperviscosity or infection such as pneumonia have been adequately treated
* No significant co-morbid medical conditions; no uncontrolled life threatening infection
* Unsupported platelet count \> 80,000/uL
* Absolute neutrophil count (ANC) \> 1000/uL
* Signed informed consent should be obtained from all patients in accordance with institutional and federal guidelines
Exclusion Criteria:
* Patients with a history of recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT interval
* Pregnant or nursing women; women of child-bearing potential must have a negative pregnancy documented within one week of registration; women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method
* Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib, thalidomide, or other agents
* Human immunodeficiency virus (HIV) positive patients
* Transaminases \> 2 x normal values
* Bilirubin \> 2 x normal values
* Active uncontrolled infection
* History of significant psychiatric illness; steroid induced psychosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02353468
Study Brief:
Protocol Section:
NCT02353468