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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03582033
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of MM
* Must have MM that is relapsed or refractory
* Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
* Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio.
* Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
* Life expectancy of greater than 3 months in the opinion of the investigator
* Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
* Parts A and D: Prior treatment with a BCMA-directed therapy
* History of another malignancy within 3 years
* Active cerebral or meningeal disease related to the underlying malignancy
* Uncontrolled Grade 3 or higher infection
* Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug.
* Combination therapy only:
1. Known intolerance to corticosteroids
2. Uncontrolled psychoses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03582033
Study Brief:
Protocol Section:
NCT03582033