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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05289492
Eligibility Criteria:
Inclusion Criteria:
* All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
* All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
* All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
* All participants must have adequate organ function.
* Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
Exclusion Criteria:
* All participants with non-secretory MM
* All participants with known auto-immune disease
* All participants with history of life-threatening toxicity related to prior immune therapy.
* All participants with active graft versus host disease after allogeneic stem cell transplantation.
* All participants with active, unstable cardiovascular function.
* All participants with active infection requiring systemic therapy.
* All participants with hypersensitivity to any of the treatments.
* All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05289492
Study Brief:
Protocol Section:
NCT05289492