Siltuximab + Teclistamab for Multiple Myeloma

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after treatment initiation or until disease progression, whichever comes first.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CRS Rate

Secondary study objectives

Hospitalization rates

Incidence of adverse events after siltuximab prophylaxis

Incidence of all grade ICANS after siltuximab prophylaxis

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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