Cytokine Release SyndromePhase 2NCT07657312
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
A Phase 2 study testing Biospecimen Collection, Bone Marrow Biopsy and Computed Tomography in people with Cytokine Release Syndrome and Recurrent Multiple Myeloma, run by Naresh Bumma at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytokine Release Syndrome, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Biospecimen Collection, Bone Marrow Biopsy and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- No uncontrolled arrhythmias
- No New York Heart Association class III-IV heart failure
- 12-lead electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤ 470 msec
- Negative test result for latent tuberculosis at screening
- Patients must provide informed consent
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2
- Fertility requirements
- Women of child bearing potential (WOCBP) must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device [IUD], hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing and continue to 6 months after study treatment ending or teclistamab/talquetamab ending, whichever is longer. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy
- Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
- A negative pregnancy test will be required for all WOCBP at screening and within 24 hours before starting treatment drugs, and with each cycle
- Breast feeding is not permitted
- Male patients must agree to use an adequate method of contraception (latex or synthetic condom) for the duration of the study and up to 6 months after study treatment ending
- Criteria also applies to azoospermic males
- Males should refrain from sperm donation during this time and continue for 6 months after study treatment ending
Who cannot join
- 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
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- 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
- Unacceptable infectious risk factors defined by any of the following criteria:
- Active tuberculosis:
- History of active or latent tuberculosis (TB) before screening
- Any signs or symptoms suggestive of active TB upon medical history and/or physical examination
- Any known recent close contact with a person with active TB.
- Active invasive fungal infections
- Other active infections, including clinically important localized infections, and patients with a history of opportunistic infections
- Unacceptable demyelinating neurologic risk factors including history or active multiple sclerosis, Guillain-Barre syndrome, optic neuritis, or peripheral demyelinating polyneuropathy
- Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is shorter) and who have not recovered from side effects of those therapies
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with active hepatitis B (defined as hepatitis B surface antigen positive [HBsAg+]); hepatitis B virus (HBV) screening is required prior to beginning therapy
- Patients with prior hepatitis B vaccine are permitted (defined as hepatitis B surface antigen negative [HbsAg-], anti hepatitis B virus surface antibody positive [Anti-HBs+], anti hepatitis C virus surface antibody negative [Anti-HBc-])
- Non-active hepatitis B (HbsAg-, Anti-HBs+, Anti-HBc+) may be enrolled if on suppressive antiviral therapy and have no detectable viral load (additional monitoring for hepatitis B reactivation is advised)
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix or breast, should not be enrolled
- Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff
- Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Naresh Bumma, MD, 614-293-6307, Naresh.Bumma@osumc.edu
Naresh Bumma, MD
About this study
Official title: Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of infliximab as CRS prophylaxis for patients with relapsed/refractory multiple myeloma (RRMM) treated with teclistamab or talquetamab therapy.
SECONDARY OBJECTIVES:
- To estimate the incidence of grade ≥ 3 CRS within cycle 1 (28 days). II. To estimate the incidence of all-grade and grade ≥ 3 neurologic toxicity (including Immune effector cell-associated neurotoxicity syndrome [ICANS]) within cycle 1 (28 days).
III. To estimate the incidence of grade ≥ 3 infection within cycle 1 (28 days). IV. To estimate the incidence of grade ≥ 3 anemia within cycle 1 (28 days). V. To estimate the incidence of grade ≥3 neutropenia within cycle 1 (28 days). VI. To estimate the incidence of grade ≥ 3 thrombocytopenia within cycle 1 (28 days).
VII. To determine the overall response rate (ORR) (per International Myeloma Working Group [IMWG] criteria).
EXPLORATORY OBJECTIVE:
- Provide a descriptive summary of changes in plasma cytokine concentrations in patients treated with teclistamab or talquetamab with prophylactic infliximab.
OUTLINE:
Patients receive infliximab intravenously (IV) on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab subcutaneously (SC) or talquetamab SC on days 1, 3, 5, 15, 22, and 28 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 positron emission tomography (PET)-computed tomography (CT) scan during screening and also blood sample collection throughout the study.
After completion of study treatment, patients are followed up at day 28.
- Being tested
- Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Infliximab, Positron Emission Tomography
- Medical subject headings
- Cytokine Release Syndrome, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET-CT
InfliximabBiological
Also called Avakine, cA2, Remicade, Remsima
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET-CT
TalquetamabBiological
Also called 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
Given SC
TeclistamabDrug
Also called JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv
Given SC
X-Ray ImagingProcedure or surgery
Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs
Undergo x-ray
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Biological: Infliximab; Procedure: Positron Emission Tomography; Biological: Talquetamab; Drug: Teclistamab; Procedure: X-Ray Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline, up to day 28
Secondary outcomes (6)
Rates of grade ≥ 3 CRS
Will be described per ASTCT guidelines. Will be reported as a proportion together with 95% confidence intervals.
Measured: From baseline up to day 28
Rates of all-grade neurologic toxicity
Adverse events (AE) will be summarized using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and will be described using frequency tables and will be reviewed for toxicity patterns. Immune effector cell-associated neurotoxicity syndrome (ICANS) will be described per ASTCT guidelines. The incidence of neurologic toxicity, including ICANS (all-grade and grade ≥ 3), will be calculated with 95% confidence intervals.
Measured: From baseline, up to day 28
Rates of grade ≥ 3 neurologic toxicity
AE will be summarized using the NCI CTCAE v 5.0 and will be described using frequency tables and will be reviewed for toxicity patterns. ICANS will be described per ASTCT guidelines. The incidence of neurologic toxicity, including ICANS (all-grade and grade ≥ 3), will be calculated with 95% confidence intervals.
Measured: From baseline, up to day 28
Incidence of grade ≥ 3 infection
AE will be summarized using the NCI CTCAE v 5.0 and will be described using frequency tables and will be reviewed for toxicity patterns.
Measured: From baseline, up to day 28
Incidence of grade ≥ 3 anemia, neutropenia, and/or thrombocytopenia
AE will be summarized using the NCI CTCAE v 5.0 and will be described using frequency tables and will be reviewed for toxicity patterns.
Measured: From baseline, up to day 28
Overall response rate (ORR)
Defined as the proportion of subjects whose best response is partial response or better and will be reported with 95% binomial exact confidence intervals. ORR among patient subgroups (patients receiving teclistamab versus talquetamab) will be compared using the Fisher exact test.
Measured: From baseline, up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start17 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Release SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naresh Bumma
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor-investigator, Naresh Bumma, Ohio State University Comprehensive Cancer Center
- Investigators
- Naresh Bumma, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657312
- Sponsor's protocol ID
- OSU-24390
- Other IDs
- NCI-2026-03836, OSU-24390
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No