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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT03266692
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent obtained prior to study procedures
* Histologically- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease
* Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible.
* Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
* ECOG 0 or 1
* Life expectancy of at least 6 months
* Absolute neutrophil (ANC) count greater than 1000/ µL
* Platelet count greater than 50,000/µL
* Estimated GFR \>30mL/min/1.73m2
Exclusion Criteria:
* Known active central nervous system (CNS) involvement by MM
* Systemic rheumatic or autoimmune diseases or acute or chronic infections
* Uncontrolled thromboembolic events or recent severe hemorrhage
* Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
* Prior treatment as follows:
* T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
* Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
* Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
* Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
* Prior BCMA-directed investigational agents at any time
* Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03266692
Study Brief:
Protocol Section:
NCT03266692