Elotuzumab + Daratumumab + Iberdomide + Dexamethasone for Multiple Myeloma

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 8

Duration: Up to 36 months

37 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Moritz Binder, MD, MPH

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for patients with multiple myeloma that has relapsed. Participants should have previously responded to treatment but now show signs of the disease returning. Specific eligibility criteria are not provided, so interested individuals should inquire further to determine if they meet the necessary requirements for participation.

Inclusion Criteria

Absolute neutrophil count (ANC) ≥ 1000/m^3

My cancer can be measured by tests.

I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

I have recently taken certain medications.

I have recently used strong medication that affects liver enzymes.

Known allergy to study medications or excipients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive iberdomide, daratumumab, elotuzumab, and dexamethasone in 28-day cycles for up to 36 cycles

Up to 36 months

Weekly visits during initial cycles, then bi-weekly or monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 3 years

Follow-up at 7 days, 30 days, then every 3-6 months

Treatment Details

Interventions

• Daratumumab
• Dexamethasone
• Elotuzumab
• Iberdomide

Trial Overview The trial is testing a combination therapy using iberdomide, daratumumab, elotuzumab, and dexamethasone to see how safe it is and what dose works best against relapsed multiple myeloma. It's in phases I/II, which means early stages of evaluating effectiveness and safety.

Participant Groups

Group I: Treatment (iberdomide, daratumumab, elotuzumab, dexamethasone) Experimental Treatment 11 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+