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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

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.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.