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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05673967
Eligibility Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at baseline
2. Confirmed diagnosis of active MM by IMWG diagnostic criteria
3. Have myeloma that is response-evaluable with measurable disease by M-protein in serum or urine as specified in the IMWG response criteria.
4. Triple-class exposed or refractory
Exclusion Criteria:
1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (POEMS) changes syndrome
2. Known MM brain lesions or meningeal involvement
3. History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
4. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy)
5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
6. Live or live attenuated vaccines
7. Treated with B-cell maturation antigen (BCMA)-directed immunotherapies (BCMA antibody-drug conjugates are not excluded).
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05673967
Study Brief:
Protocol Section:
NCT05673967