Actively Recruiting
Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma
Led by Mayo Clinic · Updated on 2025-09-30
37
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent.
- Diagnosed with relapsed multiple myeloma with 3 or fewer prior therapy lines including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 agents.
- Measurable disease.
- ECOG performance status of 0, 1, or 2.
- Hemoglobin level of at least 8.0 g/dL within 14 days prior to registration.
- Absolute neutrophil count of at least 1000/m3 within 14 days prior to registration.
- Platelet count of at least 50,000/mm3 without transfusion within 14 days prior to registration.
- Total bilirubin less than or equal to 1.5 times upper limit of normal (up to 3 times for Gilbert's syndrome) within 14 days prior to registration.
- ALT and AST less than or equal to 2 times upper limit of normal and alkaline phosphatase less than or equal to 1.5 times upper limit of normal within 14 days prior to registration.
- Calculated creatinine clearance of at least 30 ml/min within 14 days prior to registration.
- Negative pregnancy test within 7 days prior to registration for persons of childbearing potential.
- Agree to pregnancy prevention program including abstinence or use of two effective contraceptive methods during and after treatment.
- Willingness to provide informed consent and mandatory bone marrow specimens.
- Able and willing to adhere to study visit schedule and follow-up requirements.
- Willing to refrain from blood donation during and for at least 28 days after treatment.
You will not qualify if you...
- Pregnant or nursing persons, or those unwilling to use adequate contraception.
- Receiving any other concurrent chemotherapy or investigational ancillary therapy (bisphosphonates allowed).
- Known HIV positive, active hepatitis C infection, or positive for hepatitis B surface antigen at or within 3 months prior to registration.
- Evidence of significant cardiovascular disease including uncontrolled arrhythmias, recent myocardial infarction or coronary procedures within 3 months, severe heart failure, uncontrolled hypertension, or life-threatening ventricular arrhythmias.
- Moderate or severe persistent asthma or uncontrolled asthma.
- Unable or unwilling to undergo required thromboembolism prevention.
- Use of strong CYP3A4/5 inhibitors or inducers within 14 days prior to registration.
- Known allergy to study medications or their components.
- Major surgery within 14 days prior to registration.
- Treatment with investigational agents within 28 days or 5 half-lives prior to registration.
- Serious medical or psychiatric illness interfering with treatment.
- Co-morbidities interfering with trial participation such as uncontrolled infection or uncompensated heart or lung disease.
- History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
- Peripheral neuropathy grade 2 or higher.
- Recent COVID-19 infection within 14 days for mild/asymptomatic or 28 days for severe illness.
- Gastrointestinal diseases affecting iberdomide absorption.
- Received live vaccine within 90 days prior to registration.
- Prior malignancies other than multiple myeloma unless disease-free for 5 or more years, except certain noninvasive skin and cervical cancers, and incidental prostate cancer.
- Recent use of specific immunomodulating or immunosuppressive therapies within defined timeframes.
- Use of daily NSAIDs within 14 days prior unless stable dose for at least 14 days.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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