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

ConditionsCytokine Release SyndromeRecurrent Multiple MyelomaRefractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNaresh Bumma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo PET-CT

  • Infliximab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET-CT

  • Talquetamab

    Biological/Vaccine

    Given SC

  • Teclistamab

    Drug

    Given SC

  • X-Ray Imaging

    Procedure/Surgery

    Undergo x-ray

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Supportive care (Infliximab)Experimental treatment 8 interventions

Trial outcomes

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.

Time frame
From baseline, up to day 28

Secondary outcomes

1

Rates of grade ≥ 3 CRS

Will be described per ASTCT guidelines. Will be reported as a proportion together with 95% confidence intervals.

Time frame
From baseline up to day 28
2

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.

Time frame
From baseline, up to day 28
3

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.

Time frame
From baseline, up to day 28
4

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.

Time frame
From baseline, up to day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Naresh Bumma

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Janssen Research & Development, LLC

Collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborator

Source ClinicalTrials.gov
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