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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT04613557
Eligibility Criteria:
1. Documented diagnosis of MM with relapsed or refractory disease to at least two prior MM treatment regimens which should include exposure to IMiD and PIs either alone or in combination.
2. Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
3. Eastern Cooperative Oncology Group (ECOG) below or equal 2
4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
1. History or presence of clinically relevant central nervous system (CNS) tumor involvement.
2. Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
3. Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
4. Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
5. Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04613557
Study Brief:
Protocol Section:
NCT04613557