A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Siltuximab
DrugSiltuximab 11mg/kg
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: SiltuximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete CRS resolution rate
14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
Time frame
14 daysSecondary outcomes
1
CANS Resolution Rate
28-day ICANS Resolution Rate
Time frame
28 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov