Siltuximab + Teclistamab for Multiple Myeloma

Overseen By Jack Khouri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: HIV/AIDS, Hepatitis B/C, CNS pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 44 days

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion.

Research Team

Jack Khouri, MD

Principal Investigator

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio

Eligibility Criteria

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.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

I agree to either not have sex or use birth control, and not donate sperm.

My blood counts meet the required levels for treatment.

Exclusion Criteria

Pregnant or breastfeeding women

Participants with history of severe hypersensitivity reaction to siltuximab or any of the excipients

Hepatitis B infection as defined according to the American Society of Clinical Oncology guidelines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of prophylactic siltuximab prior to teclistamab infusion, followed by monitoring for CRS and ICANS

44 days

Participants are hospitalized for 9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of CRS and ICANS

6 months

Treatment Details

Interventions

• Siltuximab

Trial Overview 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.

Participant Groups

Group I: Siltuximab Experimental Treatment 2 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.

Siltuximab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Sylvant for:

• Multicentric Castleman's disease

Approved in United States as Sylvant for:

• Multicentric Castleman's disease

Approved in Canada as Sylvant for:

• Multicentric Castleman's disease

Approved in Japan as Sylvant for:

• Multicentric Castleman's disease

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Jack Khouri

Lead Sponsor

Trials

1

Jack Khouri, MD

Lead Sponsor

Trials

1