35 Participants NeededMy employer runs this trial

Infliximab for Cytokine Release Syndrome in Multiple Myeloma

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NB

Naresh Bumma, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with multiple myeloma that has come back or not responded to treatment, who have had at least 4 prior therapies. Participants need good organ function, no active infections like hepatitis B or tuberculosis, and must use reliable birth control if of childbearing potential.

Inclusion Criteria

I had BCMA CAR-T therapy more than 6 months ago.
I used a TNFα inhibitor, but it has been over 6 months since my last dose.
Patients must have hemoglobin ≥ 7g/dL
See 17 more

Exclusion Criteria

I currently have active hepatitis B infection.
I have Waldenstrom macroglobulinemia, AL amyloidosis, plasma cell leukemia, or POEMS syndrome.
I am not taking corticosteroids, except for basic hormone replacement.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive infliximab IV on day 1, followed by teclistamab or talquetamab SC on days 1, 3, 5, 15, 22, and 28

4 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Infliximab
  • Talquetamab
  • Teclistamab

Trial Overview

The study tests whether infliximab can help prevent cytokine release syndrome (CRS) in patients receiving teclistamab or talquetamab for relapsed/refractory multiple myeloma. Patients will also undergo various scans and lab tests as part of the trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (Infliximab)Experimental Treatment8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Naresh Bumma

Lead Sponsor

Janssen Research & Development, LLC

Industry Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

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

Industry Sponsor

Trials
515
Recruited
845,000+
Joaquin Duato profile image

Joaquin Duato

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

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

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

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University