Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma

Summary

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.

Conditions

• Cytokine Release Syndrome
• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

BIOLOGICAL

Talquetamab

Given SC

DRUG

Teclistamab

Given SC

PROCEDURE

X-Ray Imaging

Undergo x-ray

PROCEDURE

Computed Tomography

Undergo PET-CT

BIOLOGICAL

Infliximab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

Sponsors & Collaborators

• Janssen Research & Development, LLC

  collaborator INDUSTRY

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  collaborator INDUSTRY

• Naresh Bumma

  lead OTHER

Principal Investigators

• Naresh Bumma, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations