Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVES: I. To assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed multiple myeloma (MM). (Phase 1 \[Dose Confirmation Cohort\]) II. To determine the proportion of patients with very good partial response (VGPR) or better with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma. (Phase 2) SECONDARY OBJECTIVES: I. To assess the overall response rate (ORR) and complete response (CR or stringent complete resp…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Patien…
Interventions
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureBone Scan
Undergo bone scan
- ProcedureChest Radiography
Undergo chest x-ray
- ProcedureComputed Tomography
Undergo CT and/or PET/CT
- BiologicalDaratumumab
Given SC
- DrugDexamethasone
Given PO
Location
- Mayo Clinic in RochesterRochester, Minnesota