NCT06785415

Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma

Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 response \[sCR\]) rate with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone. (Phase 2) II. To assess the progression free survival and overall survival among patients with relapsed multiple myeloma following treatment with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone. (Phase 2) III. To assess the time to response (defined as the time between the date of first dose and the first documented evidence of a partial response or better) following treatment with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone in patients with relapsed MM. (Phase 2) IV. To describe the toxicities associated with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone in patients with relapsed MM. (Phase 2) CORRELATIVE RESEARCH: I. Examine the proportion of next generation flow cytometry assessed minimal residual disease (MRD) negative complete response following therapy with iberdomide in combination with daratumumab, elotuzumab and dexamethasone. (Phase 2) OUTLINE: This is a dose-escalation study of iberdomide followed by a dose-expansion study. Patients receive iberdomide orally (PO) once daily (QD) on days 1-21 of each cycle, daratumumab subcutaneously (SC) on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive elotuzumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 and 2, and on day 1 of subsequent cycles and dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12 or at the discretion of the treating physician. Cycles repeat every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy during screening, on study and optionally at disease progression and computed tomography (CT), bone scan, magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT during screening, on study or at the discretion of the treating physician and end of treatment (EOT). Patients may undergo chest x-ray during screening. After completion of study treatment, patients are followed up at 7 days then 30 days and every 3-6 months for up to 3 years.

Conditions

• Recurrent Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Chest Radiography	Undergo chest x-ray
PROCEDURE	Computed Tomography	Undergo CT and/or PET/CT
BIOLOGICAL	Daratumumab	Given SC
DRUG	Dexamethasone	Given PO
BIOLOGICAL	Elotuzumab	Given IV
DRUG	Iberdomide	Given PO
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2025-03-18
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2025-01-21
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study