Can a drug stop dangerous side effects of new myeloma therapies?
NCT ID NCT07657312
First seen Jun 24, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether infliximab, a drug that blocks inflammation, can prevent cytokine release syndrome (CRS) in people with relapsed or refractory multiple myeloma receiving teclistamab or talquetamab. CRS is a common and sometimes serious side effect of these treatments. The study will enroll 35 adults who have already tried at least four prior therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- infliximab
- What this could lead to
- If successful, this could provide a way to prevent severe side effects from newer myeloma treatments, making them safer and more tolerable.
- What could go wrong
- This is a small early-phase trial with only 35 participants, so results may not apply broadly. Infliximab itself can cause infections or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cytokine release syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered donor cells could outsmart relapsed myeloma
- Can a Triple-Drug cocktail tame resistant myeloma?
- Can a One-Two drug punch beat back Hard-to-Treat myeloma?
- CAR-T breakthroughs come with infection risks – new study aims to decode them
- Could a simple drug tame the dangerous side effects of CAR-T cancer therapy?
- Double-barreled CAR t therapy takes aim at hard-to-treat myeloma