Study on Talquetamab for People with Multiple Myeloma After BCMA CAR T-Cell Therapy
Sponsor: Memorial Sloan Kettering Cancer Center
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
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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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