Infliximab for Cytokine Release Syndrome in Multiple Myeloma
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infliximab IV on day 1, followed by teclistamab or talquetamab SC on days 1, 3, 5, 15, 22, and 28
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
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
Patients receive infliximab IV on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab SC or talquetamab SC per treating physician discretion. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and may undergo an x-ray or PET-CT scan during screening and also blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Naresh Bumma
Lead Sponsor
Janssen Research & Development, LLC
Industry Sponsor
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
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
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
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 ...
5.
survivornet.com
survivornet.com/articles/what-is-cytokine-release-syndrome-crs-and-how-is-it-managed/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.
6.
jons-online.com
jons-online.com/web-exclusives/cytokine-release-syndrome-associated-with-treatment-for-acute-lymphoblastic-leukemiaCytokine 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% ...
7.
gloshospitals.nhs.uk
gloshospitals.nhs.uk/media/documents/Cytokine_Release_Syndrome_Guideline_eWNGGQP.pdfManagement of Cytokine Release Syndrome
This document has been developed to assist management of patients receiving T-cell engaging bispecific antibodies for malignant haematology therapy,
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