Recruiting NCT07106671
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Siltuximab.
- Who it may be relevant to
- Registry conditions: CRS - Cytokine Release Syndrome, Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Interventions
- Drug Siltuximab
Siltuximab 11mg/kg
Primary outcome measures
- Complete CRS resolution rate [Time frame: 14 days]
Secondary outcome measures (1)
- CANS Resolution Rate [Time frame: 28 day]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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 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.
- Known intolerance to Siltuximab.
- Known central nervous system (CNS) involement.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07106671 · IIT2025006