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.
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.
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.
Single group
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Bone Scan
Procedure/SurgeryUndergo bone scan
Chest Radiography
Procedure/SurgeryUndergo chest x-ray
Computed Tomography
Procedure/SurgeryUndergo CT and/or PET/CT
Daratumumab
Biological/VaccineGiven SC
Dexamethasone
DrugGiven PO
Elotuzumab
Biological/VaccineGiven IV
Iberdomide
DrugGiven PO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Maximum tolerated dose (Phase 1)
The maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) will be defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose limiting toxicity definitions.
Proportion of patients with very good partial response (VGPR) or better (Phase 2)
Will be defined as a patient who has achieved a VGPR, complete response (CR), or stringent complete response (sCR) and maintained it on two consecutive evaluations at any time during therapy per International Myeloma Working Group (IMWG) criteria.
Overall response rate (Phase 2)
Will be assessed as stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), or progressive disease (PD).
Complete response rate (Phase 2)
Will be estimated by the total number of patients who achieve sCR or CR.
Progression-free survival (Phase 2)
Defined as the time from registration to the earliest date of documentation of disease progression, relapse, or death due to any cause.
Overall survival (Phase 2)
Overall survival (OS) is defined as the time from registration to death due to any cause.
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