Study on Talquetamab for People with Multiple Myeloma After BCMA CAR T-Cell Therapy

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06066346

This clinical trial is exploring whether the drug talquetamab can be an effective treatment for people with multiple myeloma who have already received BCMA CAR T-cell therapy. Participants in this study will have previously been treated with the BCMA CAR T-cell therapy ide-cel.

Patient Parameters

Program Overview

The purpose of this study is to determine if talquetamab is a beneficial treatment option for individuals with multiple myeloma who have undergone BCMA CAR T-cell therapy. Researchers aim to find out if talquetamab can help manage the disease in patients whose cancer has returned or not responded to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Have multiple myeloma and have been treated with an IMID, PI, and a CD38 monoclonal antibody.
  • Received BCMA CAR T-cell therapy ide-cel within 1-3 months before joining the study.
  • Low levels of specific proteins in blood and urine tests.
  • No signs of disease getting worse based on specific criteria.
  • Aged 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Recovered from any side effects of previous treatments, except for mild nerve damage or hair loss.
  • No ongoing symptoms from previous treatments like cytokine release syndrome or neurotoxicity.
  • No additional myeloma treatments after CAR T-cell therapy.
  • Adequate blood cell counts and organ function based on specific tests.
  • Oxygen levels in the blood at or above 92%.
  • Liver and kidney function within specified limits.
  • Heart function with a pumping ability of 45% or more.
  • Willing to follow the study schedule and requirements.
  • Women of childbearing potential must use effective birth control and agree to pregnancy testing.
  • Men must use condoms and agree not to donate sperm during and after the study.
  • Must sign a consent form to participate.

Exclusion Criteria

  • Previous treatment with GRPRC5D-directed therapy or T-cell redirection therapy within 3 months.
  • Received an investigational vaccine (except COVID-19) or live vaccine within 4 weeks.
  • Recent monoclonal antibody or cytotoxic therapy.
  • Recent major surgery or plasmapheresis.
  • Recent stem cell transplant or high-dose corticosteroids.
  • History of organ transplant requiring immunosuppressive therapy.
  • Recent significant bleeding or need for ongoing anticoagulant therapy.
  • History of serious brain or nervous system conditions.
  • Other active cancers or significant autoimmune diseases.
  • Positive for HIV or active hepatitis infections.
  • Recent cancer treatments with curative intent unless approved.
  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • Men planning to father a child during or after the study.
  • Known allergies to study medications.
  • Serious medical or psychiatric conditions affecting participation.
  • Uncontrolled infections or lung disease requiring oxygen.
  • Unwilling or unable to provide consent or attend follow-up visits.

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