Study on Using Infliximab to Prevent Cytokine Release Syndrome During Teclistamab or Talquetamab Treatment in Patients with Relapsed or Resistant Myeloma

Sponsor: Naresh Bumma

Sponsor score: 0

ClinicalTrials ID:NCT07657312

Provider View

This clinical trial is testing whether infliximab can help prevent cytokine release syndrome (CRS) in patients with multiple myeloma who are receiving teclistamab or talquetamab. CRS is a potential side effect of these treatments and can cause flu-like symptoms and affect various organs.

Patient Parameters

Program Overview

This study aims to find out if infliximab can effectively prevent cytokine release syndrome (CRS) in patients with multiple myeloma that has returned or is not responding to treatment. CRS can cause inflammation and symptoms like fever, nausea, and changes in blood pressure. Infliximab is a medication that may help reduce these symptoms by blocking a protein that causes inflammation. Patients will receive infliximab before starting their treatment with teclistamab or talquetamab to see if it helps prevent CRS.

Description

The main goal of this study is to see if infliximab can prevent cytokine release syndrome (CRS) in patients with relapsed or refractory multiple myeloma who are treated with teclistamab or talquetamab. Researchers will also look at how often severe CRS, neurological side effects, infections, anemia, low white blood cell counts, and low platelet counts occur during the first 28 days of treatment. Additionally, they will assess the overall response rate to the treatment.

Patients will receive infliximab through an IV on the first day, a few hours before starting their standard treatment with teclistamab or talquetamab. The treatment will continue as long as the disease does not progress and side effects are manageable. Patients will have regular blood tests and may undergo bone marrow biopsies and imaging scans to monitor their condition.

After completing the study treatment, patients will have a follow-up visit on day 28 to check their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with relapsed or refractory multiple myeloma, as defined by specific medical criteria.
  • Must have measurable disease, such as certain levels of proteins in the blood or urine.
  • Must have received at least four previous treatments, including specific types of drugs.
  • Must have adequate blood counts and organ function, including:
    • Hemoglobin level of at least 7 g/dL.
    • Neutrophil count of at least 1000/µL.
    • Platelet count of at least 50,000/µL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Must have good heart function and no serious heart conditions.
  • Must test negative for latent tuberculosis.
  • Must be able to provide informed consent and have a performance status score of 2 or lower.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
  • Men must agree to use contraception and avoid donating sperm during and after the study.

Exclusion Criteria

  • Patients with certain other blood disorders or syndromes.
  • Patients taking corticosteroids or certain other medications that could interfere with the study.
  • Patients who have received live vaccines recently.
  • Patients with active rheumatoid arthritis or similar conditions.
  • Patients with a history of severe allergic reactions to certain medications.
  • Patients with serious lung or heart conditions.
  • Patients with active infections, including tuberculosis or hepatitis.
  • Patients with a history of certain neurological disorders.
  • Patients who have recently received other investigational treatments or major surgery.
  • Patients with HIV or active hepatitis B or C infections.
  • Patients with another significant cancer or medical condition that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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