Tests siltuximab for side effects after CAR-T therapy in multiple myeloma
Tests siltuximab for cytokine release syndrome and neurotoxicity in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07106671
- Record updated
- 6 August 2025
- Original description
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.Read full original descriptionShow less
A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Inclusion: Be informed and voluntarily sign the Informed Consent Form (ICF); Age ≥18 years old; Diagnosed with multiple myeloma according to IMWG diagnostic criteria; Developed CRS (grade ≥1) and/or ICANS (grade ≥1) after CAR-T treatment.
Exclusion: Known severe cardiac conditions, including NYHA class III/IV heart failure, uncontrolled angina, arrhythmia, or hypertension, myocardial infarction within 6 months, or other uncontrolled/severe cardiovascular diseases, including prior cerebrovascular events with residual deficits; Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis; Creatinine clearance <30 mL/min; Platelet count <75,000/μL, absolute neutrophil count <1,000/μL, or hemoglobin <60 g/L at screening; ALT or AST >3× ULN, or bilirubin >2× ULN; Known intolerance to Siltuximab; Known central nervous system (CNS) involement.