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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02043860
Eligibility Criteria:
Inclusion Criteria:
1. Patients meeting criteria for symptomatic myeloma
2. Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy
3. Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
4. Patient age 18-75 years at time of enrollment
5. Karnofsky performance status of ≥70
6. Cardiac function: LVEF \>40%
7. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal
8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
9. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin)
Exclusion Criteria:
1. Patients with diagnosis of plasma cell leukemia
2. Patients with myeloma who have had any disease progression prior to enrollment
3. Patients with truly non secretory myeloma (patients with light chain disease are eligible)
4. Pregnant or breast-feeding
5. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
6. Patients who have undergone prior allograft or autologous transplant
7. Prior solid organ transplant
8. Patients receiving prior radiation to more than 20% of bone marrow containing areas
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02043860
Study Brief:
Protocol Section:
NCT02043860