Actively Recruiting
Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma
Led by Mayo Clinic · Updated on 2025-09-30
37
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone in patients with relapsed multiple myeloma, a cancer that has returned after improvement. This phase I/II trial aims to find the safest dose and assess how well this combination works, including its effects on the immune system and tumor growth. The study also looks at treatment responses and survival outcomes. Participants receive iberdomide orally once daily on days 1 to 21 of each 28-day cycle. Daratumumab is given by subcutaneous injection on specific days across the first six cycles and then less frequently. Elotuzumab is administered intravenously weekly during the first two cycles and then monthly. Dexamethasone is taken orally on selected days during the first 12 cycles or as decided by the doctor. Treatment continues for up to 36 cycles unless the disease worsens or side effects occur. During the study, patients undergo bone marrow tests, scans such as CT, MRI, PET/CT, and possibly chest x-rays. After treatment ends, participants are followed up at day 7, day 30, and then every 3 to 6 months for up to three years. Researchers monitor treatment responses, side effects, disease progression, and survival to evaluate the combination therapy's impact and safety.
CONDITIONS
Brief 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.
- Diagnosis of relapsed multiple myeloma with up to 3 prior lines of therapy including proteasome inhibitors, immunomodulatory imide drugs, and anti-CD38 drugs.
- Measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Hemoglobin level of 8.0 g/dL or higher.
- Absolute neutrophil count of 1000/m^3 or higher.
- Platelet count of 50,000/mm^3 or higher without transfusion.
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), or up to 3 times ULN for Gilbert's syndrome.
- ALT and AST less than or equal to 2 times ULN; alkaline phosphatase less than or equal to 1.5 times ULN.
- Calculated creatinine clearance of 30 ml/min or higher.
- Negative pregnancy test within 7 days prior to registration for persons of childbearing potential.
- Agree to pregnancy prevention measures including abstinence or use of two forms of contraception during and after treatment.
- Provide written informed consent.
- Willingness to provide mandatory bone marrow specimens for research.
- Able to adhere to study visits and protocol requirements.
- Willing to refrain from donating blood during and shortly after treatment.
You will not qualify if you...
- Pregnant or nursing individuals.
- Men or women of childbearing potential unwilling to use adequate contraception.
- Receiving other concurrent chemotherapy or investigational therapies (except bisphosphonates).
- Known HIV positive or active hepatitis B or C infection.
- Certain cardiovascular diseases including recent heart attack, uncontrolled arrhythmias, severe heart failure, or uncontrolled hypertension.
- Moderate to severe persistent or uncontrolled asthma.
- Unable or unwilling to follow thromboembolism prevention requirements.
- Use of strong CYP3A4/5 inhibitors or inducers within 14 days prior to registration.
- Allergies to study medications or their components.
- Major surgery within 14 days prior to registration.
- Prior investigational agent use within 28 days or 5 half-lives.
- Serious medical or psychiatric illness interfering with treatment.
- Comorbidities like uncontrolled infection or heart/lung disease.
- History of severe neuropathy (grade 2 or higher).
- Recent COVID-19 infection within specified timeframes.
- Gastrointestinal conditions affecting drug absorption.
- Recent live vaccine within 90 days.
- Prior malignancies other than multiple myeloma unless disease-free for 5 years, with specific exceptions.
- Recent use of certain immunomodulating or immunosuppressive therapies.
- Recent use of daily NSAIDs unless dose stable for 14 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 36 cycles of 28 days each
Participants receive iberdomide orally once daily on days 1-21 of each 28-day cycle, daratumumab subcutaneously on specified days during cycles 1-6 and subsequent cycles, elotuzumab intravenously on specified days during cycles 1-2 and subsequent cycles, and dexamethasone orally on specified days during cycles 1-12 or as decided by the physician. Treatment may continue up to 36 cycles if there is no disease progression or unacceptable toxicity.
Multiple visits each cycle for drug administration and assessments as per schedule
Duration - Up to 3 years
After treatment completion, participants are followed up to monitor health status and response to therapy.
Visits at 7 days, 30 days, then every 3-6 months
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
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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