Patients with multiple myeloma often experience a range of symptoms caused by the direct damage of cancer cells to bone and bone marrow function, as well as the deposition of abnormal proteins in the body. The classic presentation involves the ”CRAB“ criteria: hypercalcemia leading to thirst and confusion, renal impairment causing fatigue and edema, anemia resulting in exhaustion, paleness, and sh
Conditions
Interventions
IsaVRD Group:During the induction phase (cycles 1–12, each 4 weeks), patients received isatuximab 10 mg/kg IV (on D1, D8, D15, D22, then Q2W), combined with bortezomib 1.3 mg/m^2 SC (D1, D8, D15, D22)
during the maintenance phase (from cycle 13 onward), treatment continued with isatuximab plus bortezomib and lenalidomide (Isa+VR) until disease progression or unacceptable toxicity.
VRD Group:During the induction phase (cycles 1–12, each 4 weeks), patients received bortezomib 1.3 mg/m^2 SC (D1, D8, D15, D22), lenalidomide 25 mg PO (D1–21), and dexamethasone 20 mg PO or IV (D1, D8
during the maintenance phase (from cycle 13 onward), treatment continued with bortezomib plus lenalidomide (VR) until disease progression or unacceptable toxicity.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and 20%) and/or TP53 mutation; (2) IgH translocation with 1q21 amplification and/or del(1p32) [t(4;14), t(14;16), or t(14;20)]; (3) Biallelic or monoallelic del(1p32) with concomitant 1q21 amplification; (4) ß2-microglobulin >=5.5 mg/L with normal serum creatinine (3 months. 7. Adequate organ function defined as follows: (1) Hematologic: absolute neutrophil count >=1.0×10^9/L, platelet count >=50×10^9/L (if bone marrow plasma cell infiltration =7.5 g/dL; (2) Hepatic: total bilirubin =30 mL/min; (4) Cardiac: left ventricular ejection fraction >=50%. 8. Sexually active females of childbearing potential or male subjects must agree to use effective contraception during the study and for a specified period after the last dose. 9. Voluntarily enrolled in the study, signed informed consent, with good compliance and ability to undergo follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior systemic therapy for multiple myeloma. 2. Uncontrolled serious infection, including active hepatitis B, hepatitis C, or positive human immunodeficiency virus antibody. 3. Severe cardiovascular or cerebrovascular disease, such as myocardial infarction, unstable angina, or serious arrhythmia within 6 months prior to screening, New York Heart Association class III-IV, or left ventricular ejection fraction <50%. 4. Severe neurological or psychiatric disorder affecting informed consent or protocol compliance. 5. Known hypersensitivity to isatuximab, bortezomib, lenalidomide, dexamethasone, or any excipient. 6. Pregnant or lactating females. 7. Simultaneously enrolled in another interventional clinical trial, or received other anti-tumor therapy within the specified period prior to first dose in this study. 8. Any other condition deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;MRD negative rate at 18 months;Progress free survival;Objective remission rate; | — |
Countries
China
Contacts
Public ContactZhuang Junling
Peking Union Medical College Hospital
Outcome results
None listed