Actively Recruiting
A Phase I/II Study of Elotuzumab, Iberdomide, and Dexamethasone After Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Led by Omar Nadeem, MD · Updated on 2025-12-11
49
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
Sponsors
O
Omar Nadeem, MD
Lead Sponsor
C
Celgene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Elotuzumab and Iberdomide therapy following Idecabtagene Vicleucel treatment in adults with relapsed and refractory multiple myeloma. This phase I/II, open-label, non-randomized study aims to assess the effectiveness and safety of this combination, with Elotuzumab and dexamethasone already approved for multiple myeloma, while Iberdomide is still under investigation. The study is supported by Bristol-Myers Squibb and Celgene, providing the study drugs and funding. Participants will receive study treatment through a dose escalation phase followed by a dose expansion phase. Treatment involves cycles of Iberdomide taken orally daily for 21 days, alongside dexamethasone and Elotuzumab given on specific days within each 28-day cycle. The dose escalation phase determines the maximum tolerated dose of Iberdomide, starting at Dose Level 0 and increasing to Dose Level 1. After treatment concludes, participants have a follow-up visit at 14 days and regular follow-ups every 28 days for up to two years. During the study, participants undergo various assessments including bone marrow biopsies, blood and urine tests, ECGs, X-rays, and imaging scans such as PET, CT, or MRI. Researchers monitor treatment effects, side effects, and disease progression through measures like dose limiting toxicities, maximum tolerated dose, and progression-free survival at 12 months. Secondary outcomes include evaluating minimal residual disease, time to progression, response duration, overall survival, and treatment-related toxicities. Participants are expected to be involved in study visits and evaluations from treatment start through follow-up periods lasting up to four years.
CONDITIONS
Brief Title
Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with multiple myeloma based on standard IMWG criteria
- Provided voluntary written informed consent
- Treated with at least 4 prior lines of anti-myeloma therapy including an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
- Received idecabtagene vicleucel with at least a partial response within 90 days of infusion
- ECOG performance status of 2 or less
- Screening labs within required parameters including ANC ≥ 1,000 cells/dL, platelet count ≥ 75,000 cells/dL, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 x ULN (or < 3.0 mg/dL for Gilbert Syndrome), AST or ALT ≤ 3x ULN, and creatinine clearance ≥ 30 ml/min
- Age 18 years or older
- Able and willing to provide informed consent
- Female participants of childbearing potential must have negative pregnancy tests and agree to use specified contraception during and 28 days after study drug
- Sexually active males must agree to use specified contraception during and 28 days after study drug
- Agree to abstain from donating blood products or semen during and 28 days after study drug
You will not qualify if you...
- Prior exposure to Iberdomide
- Participation in other clinical trials with investigational agents within 30 days before and during this trial
- Diagnosis or treatment of another malignancy within 3 years, except certain low-risk skin cancers or prostate cancer
- Known central nervous system involvement
- Use of strong CYP3A or CYP1A2 inhibitors or inducers within 14 days before treatment
- Any medical, psychiatric, or social condition posing excessive risk or limiting compliance
- Active graft versus host disease after allogeneic stem cell transplantation
- Major surgery or radiation therapy within 14 days before treatment, except limited radiation for bone pain beyond 14 days
- Active or uncontrolled cardiovascular conditions including recent serious events
- Recent cytotoxic therapies or live vaccines within specified time frames
- Prior peripheral stem cell transplant within 12 weeks
- Prior allogeneic stem cell transplant with active graft-versus-host disease
- High daily corticosteroid requirements above specified limits
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- POEMS syndrome
- Infection requiring systemic antibiotic therapy within 7 days, unless resolved
- Active viral infections of HIV, hepatitis B or C (with certain exceptions)
- Pregnant or lactating female patients
- Receiving other investigational agents
- History of severe hypersensitivity to IMiDs or study drug components
- Inability to tolerate thromboprophylaxis
- Not recovered from effects of prior chemotherapy above grade 2
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 visit (in-person)
Duration - Until end of treatment as determined by the study protocol
Participants receive study treatment with Elotuzumab, Iberdomide, and Dexamethasone in 28-day cycles. During Cycles 1 and 2, Iberdomide is taken daily on Days 1-21, and Elotuzumab and Dexamethasone are given on Days 1, 8, 15, and 22. From Cycle 3 onward, Iberdomide is taken daily on Days 1-21, while Elotuzumab and Dexamethasone are administered on Day 1 of each cycle.
Multiple visits per 28-day cycle including baseline, treatment days, and end of treatment visit
Duration - Up to 2 years
Participants have follow-up visits every 28 days for up to 2 years after completing treatment to monitor health and response to therapy.
Monthly visits every 28 days
Trial Site Locations
Total: 3 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
O
Omar Nadeem, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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