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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06785415
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Sep 2025
Primary completion
Apr 1, 2031
Completion
Apr 1, 2031

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (iberdomide, daratumumab, elotuzumab, dexamethasone)
    Patients receive iberdomide PO QD on days 1-21 of each cycle, daratumumab 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 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 CT, bone scan, MRI or PET/CT during screening, on study or at the discretion of the treating physician and EOT. Patients may undergo chest x-ray during screening.

Primary Outcome Measure

Maximum tolerated dose (Phase 1) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Moritz Binder, MD, MPH (PRINCIPAL_INVESTIGATOR)

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