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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07334535
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed Multiple myeloma ，meeting the IMWG 2025 definition of high-risk MM (any one criterion):
(1) Del(17p) (\>20% of plasma cells) and/orTP53 mutation or（2）One of these translocations cooccurring with 1q+ and/or del(1p32) , or t(4;14), or t(14;16), or t(14;20) or （3） Monoallelic del(1p32) along with 1q+ or biallelic del(1p32) or（4） High β2M (\>5.5 mg/dL) with normal creatinine (\<1.2 mg/dL) or（5）Or presents with any other high-risk feature: meeting diagnostic criteria for primary plasma cell leukemia or presence of extramedullary plasmacytoma at baseline;
* Age ≥18 years and ≤80 years;
* Not eligible for autologous hematopoietic stem cell transplantation or has declined transplantation for other reasons.
* ECOG score 0-2
* Expected survival time \> 3 months
* Sufficient organ function is defined as follows: absolute neutrophil count ≥ 1.0×10\^9/L, platelet count ≥ 50×10\^9/L (when the proportion of bone marrow plasma cells is \<50%), hemoglobin ≥ 7.5 g/dL; total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance rate ≥ 30 mL/min; left ventricular ejection fraction ≥ 50%.
* Fertile female or male subjects must agree to take effective contraceptive measures during the study period and within the specified time after the last administration.
* Voluntarily participated in this study, signed the informed consent form, had good compliance, and was cooperative during the follow-up.
Exclusion Criteria:
* Prior systemic anti-myeloma therapy;
* Viral infections including HBV, HCV, HIV, etc.;
* Serious cardiovascular and cerebrovascular diseases, such as: within 6 months before screening, myocardial infarction, unstable angina pectoris, severe arrhythmia, New York Heart Function Classification III-IV grade, or left ventricular ejection fraction \<50%.
* Severe neurological or mental disorders that affect the ability to give informed consent or comply with the protocol.
* Had an allergic reaction to isatuximab, bortezomib, lenalidomide, dexamethasone or any excipients
* Pregnant or lactating women.
* Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study.
* The researcher believes that there are any other circumstances unsuitable for participating in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07334535
Study Brief:
Protocol Section:
NCT07334535