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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03287804
Eligibility Criteria:
Key Inclusion Criteria:
1. Male or female patients, aged ≥ 18.
2. Willing and able to give written, informed consent.
3. Confirmed diagnosis of MM.
4. Measurable disease as defined by IMWG.
5. Relapse or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor, alkylator and immunomodulatory therapy (IMiD), or have "double refractory" disease to a proteasome inhibitor and IMiD.
6. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening and confirmed before receiving study treatment.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
8. Peripheral blood total lymphocyte count \> 0.5 x 10⁹/L.
Key Exclusion Criteria:
1. Women who are pregnant or lactating.
2. Prior treatment with investigational or approved gene therapy or cell therapy products.
3. Patient has previously received an allogenic stem cell transplant.
4. Clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event.
5. Left Ventricular Ejection fraction \< 50 unless the institutional lower limit of normal is lower.
6. Significant liver disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN, or total bilirubin \> 2.0 mg/dL or evidence of end stage liver disease (e.g. ascites, hepatic encephalopathy).
7. Chronic renal impairment requiring dialysis, or calculated creatinine clearance \< 30 mL/min
8. Active infectious bacterial or viral disease (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-lymphotropic virus or syphilis) requiring treatmenUse of rituximab within the last 3 months.
9. Active autoimmune disease requiring immunosuppression.
10. Received any anti-myeloma therapy within the last 21 days prior to preconditioning or 10 days prior to leukapheresis; steroids of up to 160 mg of dexamethasone are permitted so long as \> 7 days post-dose prior to pre-conditioning or leukapheresis.
11. Known allergy to albumin, dimethyl sulfoxide (DMSO), cyclophosphamide or fludarabine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03287804
Study Brief:
Protocol Section:
NCT03287804