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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT03318861
Eligibility Criteria:
Key Inclusion Criteria:
1. Measurable relapsed or refractory myeloma as defined by the International Myeloma Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or progressive myeloma that is refractory to a regimen containing both a PI and an IMiD.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
* Absolute neutrophil count (ANC) ≥ 1,000/µL
* Platelet count ≥ 75,000/µL
* Absolute lymphocyte count ≥ 100/µL
* Creatinine clearance above limits set in the protocol for each cohort
* Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
* Baseline oxygen saturation \> 92% on room air and no clinically significant pleural effusion
Key Exclusion Criteria:
1. Plasma cell leukemia
2. Non-secretory multiple myeloma
3. History of Central nervous system (CNS) involvement by multiple myeloma
4. Prior CAR therapy or other genetically modified T cells
5. Inadequate washout from prior therapy
6. Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
7. History of active autoimmune disease
8. History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
9. Recent history of other (non multiple myeloma) cancer
10. Active viral, fungal, bacterial or other infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03318861
Study Brief:
Protocol Section:
NCT03318861