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

NCT07657312 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-24390NCI-2026-03836
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of all-grade cytokine release syndrome (CRS)

  Will be described per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Will be reported as a proportion together with 95% confidence intervals.

  From baseline, up to day 28

Secondary Outcomes (6)

• Rates of grade ≥ 3 CRS

  From baseline up to day 28

• Rates of all-grade neurologic toxicity

  From baseline, up to day 28

• Rates of grade ≥ 3 neurologic toxicity

  From baseline, up to day 28

• Incidence of grade ≥ 3 infection

  From baseline, up to day 28

• Incidence of grade ≥ 3 anemia, neutropenia, and/or thrombocytopenia

  From baseline, up to day 28

Study Arms (1)

Supportive care (Infliximab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Biological: Infliximab; Procedure: Positron Emission Tomography; Biological: Talquetamab; Drug: Teclistamab; Procedure: X-Ray Imaging

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Supportive care (Infliximab)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Supportive care (Infliximab)

Computed Tomography PROCEDURE

Undergo PET-CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Supportive care (Infliximab)

Infliximab BIOLOGICAL

Given IV

Also known as: Avakine, cA2, Remicade, Remsima

Supportive care (Infliximab)

Positron Emission Tomography PROCEDURE

Undergo PET-CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Supportive care (Infliximab)

Talquetamab BIOLOGICAL

Given SC

Also known as: Anti-CD3/Anti-GPRC5D Bispecific Monoclonal Antibody JNJ-64407564, GPRC5D x CD3 Bispecific Antibody JNJ-64407564, GPRC5D x CD3 DuoBody Antibody JNJ-64407564, GPRC5D/CD3 DuoBody Antibody JNJ-64407564, Humanized GPRC5D x CD3 DuoBody Antibody JNJ-64407564, JNJ 64407564, JNJ-64407564, JNJ64407564, Talquetamab-tgvs

Supportive care (Infliximab)

Teclistamab DRUG

Given SC

Also known as: JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv, Tecvayli

Supportive care (Infliximab)

X-Ray Imaging PROCEDURE

Undergo x-ray

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray

Supportive care (Infliximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:
• Serum M-protein ≥ 0.5 g/dl
• Urine monoclonal protein ≥ 200 mg/24h
• Involved free light chain (FLC) level ≥ 10mg/dl (≥ 100mg/l) and an abnormal serum free light chain ratio (\< 0.26, or \> 1.65)
• Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
• Prior B-cell maturating antigen (BCMA) chimeric antigen receptor (CAR)-T is permitted but at least 6 months must have lapsed from CAR-T exposure
• Prior tumor necrosis factor alpha (TNFα) inhibitor use for a concomitant condition (ex. Rheumatoid arthritis) is permitted but at least 6 months must have lapsed from exposure
• Patients must have hemoglobin ≥ 7g/dL
• Absolute neutrophil count (ANC) ≥ 1000/µL
• Platelets ≥ 50,000/µL
• Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \< 2.5 X the ULN
• Calculated creatinine clearance of ≥ 30ml/min using Modification of Diet in Renal Disease (MDRD) formula
• Patients must have adequate cardiac function as evidenced by:
• Left ventricular ejection fraction ≥ 30%; baseline echocardiography (ECHO) is not required if ECHO was done within the preceding 6 months and patients do not have new signs/symptoms suggestive of heart failure

You may not qualify if:

• Patients with Waldenstrom macroglobulinemia, primary amyloid light chain (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
• Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
• Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
• Live vaccines should not be given concurrently with infliximab. Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and least 4 weeks after treatment
• Clinically active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and/or ankylosing spondylitis (AS), or concurrent use of abatacept, anakinra, rituximab, or other biologic products approved to treat these diseases within the preceding 6 months
• Patients with history of anaphylaxis or hypersensitivity to etanercept, infliximab, adalimumab, certolizumab pegol, or golimumab
• Unacceptable respiratory risk factors defined by any one of the following criteria:
• Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal
• Moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
• Unacceptable cardiac risk factors defined by any of the following criteria:
• Left ventricular ejection fraction \< 30%
• Complete left bundle branch, bifascicular block or clinically significant abnormal electrocardiogram (EKG) finding at screening
• A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval \> 470 msec using Fridericia's QT correction formula; a family history of Long QT Syndrome
• Myocardial infarction within 6 months
• Unstable angina

Sponsors & Collaborators

• Naresh Bumma: lead
• Janssen Research & Development, LLC: collaborator
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Cytokine Release Syndrome; Multiple Myeloma

Interventions

Specimen Handling; Biopsy; Infliximab; CT-P13; Magnetic Resonance Spectroscopy; talquetamab; X-Rays; Phantoms, Imaging

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Equipment and Supplies

Study Officials

• Naresh Bumma, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

1-800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

US (1)