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Monoclonal Antibodies

Siltuximab for Cytokine Release Syndrome

Phase 2
Waitlist Available
Led By Jack Khouri, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after treatment initiation or until disease progression, whichever comes first.
Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of using a drug called siltuximab before giving another drug called teclistamab. Siltuximab is a new drug that targets

Who is the study for?
This trial is for individuals with relapsed or refractory multiple myeloma, who may experience severe inflammatory reactions (CRS and ICANS) from teclistamab treatment. Specific eligibility criteria are not provided, but typically include factors like age, disease stage, prior treatments, and overall health status.Check my eligibility
What is being tested?
The study tests if a dose of siltuximab before teclistamab infusion can reduce the rates and severity of CRS and ICANS in patients. Siltuximab targets IL-6, a cytokine involved in inflammation. It's approved for Castleman's disease but experimental for this prophylactic use.See study design
What are the potential side effects?
Potential side effects of siltuximab could include allergic reactions, risk of infection due to immune system suppression, liver abnormalities, nausea or vomiting. The exact side effects will be monitored as part of the trial's safety assessment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after treatment initiation or until disease progression, whichever comes first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after treatment initiation or until disease progression, whichever comes first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CRS Rate
Secondary outcome measures
Hospitalization rates
Incidence of adverse events after siltuximab prophylaxis
Incidence of all grade ICANS after siltuximab prophylaxis
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SiltuximabExperimental Treatment2 Interventions
Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up mentioned below. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siltuximab
2011
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
453 Previous Clinical Trials
31,849 Total Patients Enrolled
Jack KhouriLead Sponsor
Jack Khouri, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective patients still eligible to participate in this ongoing medical study?

"As per the details on clinicaltrials.gov, recruitment for this study is currently closed. The trial was initially listed on July 1st, 2024 and last modified on April 2nd, 2024. Despite this particular study not accepting new participants at present, it's noteworthy that there are a total of 2301 ongoing trials actively seeking enrollees."

Answered by AI

What are the risks associated with Siltuximab when used in patients?

"The safety of siltuximab is rated at 2 by our team due to this being a Phase 2 trial, where there is existing data supporting its safety but not yet confirming its effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM
Jack Khouri 2024. "Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06352866.
~13 spots leftby Apr 2025
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