Study on ATRA and Carfilzomib for Patients with Multiple Myeloma

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06536413

This clinical trial is exploring a new treatment combination using All-Trans Retinoic Acid (ATRA) and Carfilzomib for patients with multiple myeloma, a type of blood cancer, who have not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing the safety and effectiveness of combining two drugs, All-Trans Retinoic Acid (ATRA) and Carfilzomib, to treat multiple myeloma, a blood cancer that affects plasma cells. Multiple myeloma is common in older adults and can become resistant to standard treatments over time. Carfilzomib is a drug that targets cancer cells, and ATRA is a form of vitamin A that may help make cancer cells more sensitive to Carfilzomib. The study aims to find out if this combination can help patients whose cancer has not responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with multiple myeloma that has returned or not responded to treatment.
  • Previously treated with at least three different therapies, including Carfilzomib, and did not respond after two cycles or relapsed during treatment.
  • Able to understand and sign a consent form.
  • In good general health, with a performance status score of 0 to 2.
  • Have adequate organ function, including:
    • Hemoglobin level of at least 8 g/dL.
    • Platelet count over 75,000.
    • Neutrophil count over 1,000 per microliter.
    • Heart function with an ejection fraction over 50%.
    • Kidney function with creatinine clearance of at least 30 ml/min.
    • Liver enzymes and bilirubin within specified limits.
  • Have measurable disease that requires treatment, such as:
    • Serum M protein of at least 0.5 g/dL.
    • Urine M protein of at least 200 mg/24 hours.
    • Abnormal serum free light chain levels.
  • If previously had a stem cell transplant, must be fully recovered and more than 60 days post-transplant.
  • Willing to have a bone marrow biopsy if needed.
  • Life expectancy of at least 6 months.
  • Women and men must use effective birth control methods during the study and for a specified time after.

Exclusion Criteria

  • Have a type of multiple myeloma that does not produce enough protein to measure.
  • Have plasma cell leukemia or amyloidosis.
  • Have cancer that has spread to the brain.
  • Are pregnant or breastfeeding.
  • Have a severe or active infection or fever within a week of starting the study.
  • Have had allergic reactions to Carfilzomib or similar drugs.
  • Have had a bone marrow or organ transplant.
  • Have serious heart problems or other significant health issues that could interfere with the study.
  • Have been on experimental treatments within 12 weeks before joining the study.
  • Have had problems with proteasome inhibitors like Carfilzomib in the past.
  • Are considered unfit for the study by the investigator.

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