Isa-VRD in TIE HRMM

Korábbi kezelés

• Prior systemic anti-myeloma therapy;
• Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study.

Más betegség

• Viral infections including HBV, HCV, HIV, etc.;
• 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

Laborértékek

• 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%.

Egyéb

• Pregnant or lactating women.
• The researcher believes that there are any other circumstances unsuitable for participating in this study.

• 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.