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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02248402
Eligibility Criteria:
Inclusion Criteria:
* Relapsed or refractory multiple myeloma who received at least one prior therapy including thalidomide, bortezomib, or lenalidomide-containing regimen
* Subjects with measurable disease defined as at least one of the following Serum M-protein ≥ 1.0 g/dL Urine M-protein ≥ 400 mg/24hr
* Eastern Cooperative Oncology Group Performance Status ≤ 2
* Hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L): Prior red blood cell transfusion or recombinant human erythropoietin use is allowed.
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
* Aspartate aminotransferase (AST) \< 3 times the upper limit of normal
* Alanine aminotransferase (ALT) \< 3 times the upper limit of normal
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
* Smoldering or indolent myeloma
* Uncontrolled or severe cardiovascular disease (cardiac ejection fraction\<0.5, Severe conduction disorder )
* Sepsis or current active infection
* Pregnancy or breastfeeding
* Received other immunotherapy treatment
* Clinically significant autoimmune disease
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02248402
Study Brief:
Protocol Section:
NCT02248402