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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05438394
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old, male or female;
2. Relapsed or refractory multiple myeloma according to IMWG. There is no requirement for the number of previous treatment lines in this study
3. With any one of the following measurable indicators: serum protein electrophoresis (SPEP) ≥ 1 g/dL (10 g/L), if IgA, IgD, IgE or IgM multiple myeloma subjects, ≥ 0.5 g/dL (≥ 5 g/L); urine M protein ≥ 200 mg/24h; serum free light chain (FLC) ≥ 10 mg/dL and abnormal serum free light chain kappa/lambda ratio;
4. Life expectancy ≥ 6 months;
5. ECOG score ≤ 2;
6. ECG QT interval ≤ 470 ms;
7. Neutrophil ≥ 1.0\*10\^9/L, platelet ≥ 75\*10\^9/L (or 50 \*10\^9/L if plasma cell infiltration in bone marrow more than 50%);
8. Tbil ≤1.5 ULN，AST and ALT≤3.0 ULN （Gilbert syndrome except);
9. eGFR ≥ 45 ml/min or creatinine ≤ 2mg/dl
10. Understand the contents of this study and have signed the informed consent form.
Exclusion Criteria:
1. primary amyloidosis, MGUS, or smoldering multiple myeloma or plasma cell leukemia (according to the World Health Organization criteria: peripheral blood ≥ 5%) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin) ;
2. primary refractory disease (i.e., no at least MR response to any prior therapy);
3. combined clinically significant comorbidities (investigator judged);
4. the presence of active infection;
5. history of other malignant tumors (except multiple myeloma) within 3 years before signing the informed consent;
6. Pregnant or lactating women;
7. radiotherapy or other anti-myeloma treatment within 14 days before signing the informed consent;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05438394
Study Brief:
Protocol Section:
NCT05438394