Actively Recruiting
Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM
Led by Omar Nadeem, MD · Updated on 2025-12-11
49
Participants Needed
3
Research Sites
530 weeks
Total Duration
On this page
Sponsors
O
Omar Nadeem, MD
Lead Sponsor
C
Celgene
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. The names of the study drugs involved in this study are: * Iberdomide (a type of cereblon E3 ligase modulator) * Elotuzumab (a type of monoclonal antibody) * Dexamethasone (a type of steroid)
CONDITIONS
Official 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 before any study-related procedures
- Treated with at least 4 prior lines of anti-myeloma therapy including immunomodulating agent, proteasome inhibitor, and anti-CD38 monoclonal antibody
- Received idecabtagene vicleucel following FDA-approved guidelines and achieved at least a partial response within 90 days of infusion
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Laboratory values within specified limits: ANC ≥ 1,000 cells/dL, platelet count ≥ 75,000 cells/dL without recent transfusions, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 times upper limit of normal (or ≤ 3.0 mg/dL if Gilbert Syndrome), AST or ALT ≤ 3 times upper limit of normal, creatinine clearance ≥ 30 ml/min
- Age 18 years or older
- Ability and willingness to sign informed consent
- Female participants of childbearing potential must have two negative pregnancy tests before enrollment and agree to use specified contraception during the study and for 28 days after last dose
- Sexually active males must agree to use specified contraception during the study and for 28 days after last dose
- All participants must agree to abstain from donating blood or sperm during treatment and for 28 days after last dose
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 study
- Diagnosis or treatment for another malignancy within 3 years except for certain skin cancers or low-risk prostate cancer after curative therapy
- Known central nervous system involvement
- Systemic treatment within 14 days before study start with strong CYP3A inducers or strong CYP1A2 inhibitors
- Medical, psychiatric, or social conditions that increase risk or limit study compliance
- Active graft versus host disease after allogeneic stem cell transplantation
- Major surgery or radiation therapy within 14 days before starting therapy, except limited radiation for bone pain more than 14 days before therapy
- Active or uncontrolled cardiovascular conditions including uncontrolled hypertension, arrhythmias, symptomatic heart failure, unstable angina, recent thromboembolic event or heart attack within 6 months
- Recent therapies prior to treatment: cytotoxic therapies within 21 days (42 days for nitrosoureas), live vaccines within 30 days, IMiDs or proteasome inhibitors within 14 days, other investigational therapies or monoclonal antibodies within 4 weeks, peripheral stem cell transplant within 12 weeks, allogeneic stem cell transplant with active graft-versus-host disease
- Requirement for corticosteroids above specified stable doses, except inhaled corticosteroids
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- POEMS syndrome
- Infection requiring systemic antibiotics within 7 days, except prophylactic antibiotics or resolved infections
- Active viral infections with HIV, hepatitis B or C (except vaccination seropositivity and HBV PCR negative)
- Pregnant or lactating females
- Receiving other investigational agents
- History of severe hypersensitivity to IMiDs or study medications
- Inability to tolerate thromboprophylaxis
- Not fully recovered from prior chemotherapy effects (greater than Grade 2 CTCAE v5)
AI-Screening
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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
CONTACT
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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