About this trial
This phase I/II trial tests the safety, side effects, and best dose of iberdomide and how well it works in combination with daratumumab, elotuzumab, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Elotuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving iberdomide in combination with daratumumab, elotuzumab, and dexamethasone may be safe, tolerable and/or effective in patients with relapsed multiple myeloma.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of signing the informed consent form (ICF).
Diagnosis of relapsed multiple myeloma with ≤ 3 prior lines of therapy including treatment with proteasome inhibitors (i.e., ixazomib, carfilzomib, bortezomib), immunomodulatory imide drugs (i.e., lenalidomide, pomalidomide), and anti-CD38 drugs (i.e., daratumumab, isatuximab). Patients are required to have received a proteasome inhibitor, immunomodulatory imide drug, or combination of the two drug classes during first-line treatment.
Note: Prior treatment with iberdomide is not allowed. Patients should not be refractory simultaneously to all other drugs in the combination.
Measurable disease.
Disqualifiers
Pregnant persons
Nursing persons
Men or women of childbearing potential who are unwilling to employ adequate contraception.
Receiving any other concurrent chemotherapy, or any ancillary therapy considered investigational.
Trial design
Treatments tested in this trial
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Bone Scan
- Chest Radiography
- Computed Tomography
- Daratumumab
- Dexamethasone
- Elotuzumab
- Iberdomide
- Magnetic Resonance Imaging
- Positron Emission Tomography