Study on Mezigdomide, Carfilzomib, and Dexamethasone for Treating Relapsed or Resistant Multiple Myeloma with Tumors Outside the Bone Marrow

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06627751

This clinical trial is testing a combination of three drugs—Mezigdomide, Carfilzomib, and Dexamethasone—to see if they can effectively treat multiple myeloma that has returned or is not responding to treatment, especially when the cancer has spread to soft tissues or organs outside the bone marrow.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—Mezigdomide, Carfilzomib, and Dexamethasone—can help treat multiple myeloma that has come back or is not responding to treatment. This type of cancer can sometimes spread to areas outside the bone marrow, like soft tissues or organs. Mezigdomide works by blocking important processes in cancer cells and may help the immune system fight the cancer. Carfilzomib stops cancer cells from growing by blocking certain enzymes. Dexamethasone is a steroid that helps kill myeloma cells. Together, these drugs may be more effective in killing cancer cells in patients with relapsed or resistant multiple myeloma that has spread outside the bone marrow.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have relapsed or resistant multiple myeloma with at least one tumor outside the bone marrow that can be biopsied.
  • Have measurable disease based on specific medical tests.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1 x 10^9/L.
    • Platelet count of at least 75 x 10^9/L.
    • Total bilirubin level within 1.5 times the normal limit.
    • Liver enzymes within 3 times the normal limit.
    • Kidney function with creatinine clearance of at least 30 mL/min.
    • Heart function with a pumping ability of at least 40%.
  • Women of childbearing potential must use effective birth control during the study and for a specified time after treatment.
  • Men must use contraception during the study and for a specified time after treatment.
  • Must understand the study and sign a consent form before participating.

Exclusion Criteria

  • Have a history of severe allergic reactions to any of the study drugs or similar medications.
  • Are taking certain medications that affect the liver or stomach within two weeks before starting the study.
  • Cannot or will not take blood clot prevention medication as required by the study.
  • Have active bleeding or are resistant to platelet transfusions.
  • Have medical conditions that pose a high risk or affect participation in the study.
  • Have an active infection requiring treatment within the past 14 days.
  • Have had another cancer, except for certain non-invasive cancers, unless free of disease for at least 3 years.
  • Are receiving other treatments for multiple myeloma, except for certain medications for symptom management.
  • Are pregnant or breastfeeding.
  • Have serious mental health issues, alcoholism, or drug addiction that may interfere with the study.
  • Have active HIV or hepatitis B or C infections.
  • Have certain rare conditions like systemic amyloidosis or POEMS syndrome.
  • Have had a stem cell transplant within 12 weeks before the study.
  • Have had radiation therapy within 14 days before starting the study, unless it covered a small area.
  • Cannot tolerate steroid therapy.
  • Have uncontrolled illnesses like heart failure or severe heart problems.
  • Are resistant to Carfilzomib in the most recent treatment.
  • Have been treated with Mezigdomide before.
  • Cannot undergo conscious sedation.
  • Are unwilling or unable to follow the study requirements.
  • Have any condition that makes participation in the study unsuitable.

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