35 Participants NeededMy employer runs this trial

Infliximab for Cytokine Release Syndrome in Multiple Myeloma

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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 trial explores whether infliximab can prevent cytokine release syndrome (CRS) in patients with relapsed or unresponsive multiple myeloma, a type of blood cancer. CRS can cause severe flu-like symptoms and affect organs like the heart and lungs. Infliximab may help by blocking a protein that triggers inflammation. This trial could suit individuals who have undergone multiple myeloma treatments, including at least four different therapies, and still experience disease return or resistance. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that infliximab, tested to prevent cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab, has been safe in past studies. Infliximab is already approved for other conditions, indicating it has been well-tolerated by people before.

CRS can be serious, causing symptoms like fever, nausea, and changes in heart rate or blood pressure. It can sometimes affect the brain, leading to confusion or trouble speaking. Infliximab works by blocking a protein that causes inflammation, which might help reduce these risks.

Although specific data on infliximab's use with teclistamab or talquetamab is not available here, its previous approval for other uses suggests it is safe for humans. Prospective trial participants can find reassurance in this background regarding the treatment's safety.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for multiple myeloma, which focus on targeting cancer cells directly, infliximab is being explored for its potential to manage cytokine release syndrome (CRS), a serious side effect of some cancer therapies. Infliximab works by specifically blocking tumor necrosis factor-alpha (TNF-alpha), a key player in the inflammatory process of CRS. Researchers are excited because this approach could help make treatments like talquetamab and teclistamab safer and more tolerable for patients, allowing them to benefit from these promising therapies without severe inflammatory side effects.

What evidence suggests that infliximab could be effective for preventing cytokine release syndrome in multiple myeloma?

Research has shown that infliximab, which participants in this trial may receive as supportive care, can help prevent cytokine release syndrome (CRS), a serious side effect of treatments like teclistamab and talquetamab. These treatments, also part of this trial, are used for multiple myeloma, a type of blood cancer, but can cause CRS in up to 87% of patients. Infliximab blocks a protein called tumor necrosis factor-alpha (TNF-α), which is involved in inflammation. By blocking TNF-α, infliximab may reduce inflammation and help prevent CRS symptoms such as fever and low blood pressure. While more research is needed, early evidence suggests that infliximab shows promise in managing CRS in patients receiving these newer cancer treatments.12367

Who Is on the Research Team?

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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

Citations

View of Teclistamab-associated cytokine release syndrome ...

Teclistamab-associated cytokine release syndrome inmultiple myeloma: a case-based literature review ofmechanisms, management, and clinical ...

KarMMa: characterizing incidence of CRS in R/R myeloma

Ankit Kansagra, MD, UT Southwestern Medical Center, Dallas, TX, discusses the results of an analysis examining the incidence of cytokine ...

Cytokine Release Syndrome (CRS) and CAR-T

Cytokine release syndrome (CRS) is the most common side effect of CAR-T therapy and according to the study linked below, CRS occurs in more than 60% of ...

A Systematic Meta-Analysis of Cytokine Release ...

Estimates of how commonly patients experience CRS or ICANS vary depending on the type and stage of the cancer and specific treatment. CRS occurs in 87% of ...

What is Cytokine Release Syndrome (CRS) and How is It ...

While CAR T-cell therapy show enormous promise in treating multiple myeloma, it also comes with some risk in the form of side effects.

Cytokine Release Syndrome Associated with Treatment for ...

CRS risk varies by disease factors as well as specific therapy. the incidence of CRS ranged from 59% to 90%, and the incidence of serious CRS ranged from 12% ...

Management of Cytokine Release Syndrome

This document has been developed to assist management of patients receiving T-cell engaging bispecific antibodies for malignant haematology therapy,