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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03271632
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).
* Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.
* MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.
* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
* Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
* Residual disease after primary therapy and not eligible for ASCT
* Expected survival \> 12 weeks
* Creatinine \< 2.5 mg/dl
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Any relapse after prior SCT is eligible regardless of other prior therapy
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given
Exclusion Criteria:
* Pregnant or lactating women
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation
* HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03271632
Study Brief:
Protocol Section:
NCT03271632