Actively Recruiting
Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
Led by Emory University · Updated on 2026-04-17
68
Participants Needed
1
Research Sites
425 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients. Immunotherapy with iberdomide may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Dexamethasone is a synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland), and is used with other drugs in the treatment of some types of cancer. Giving iberdomide with dexamethasone my improve time to progression to symptomatic myeloma with improved tolerability.
CONDITIONS
Official Title
Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have intermediate- or high-risk smoldering multiple myeloma confirmed by bone marrow plasma cells \u2265 20%, abnormal serum free light chain ratio > 20, or serum monoclonal protein \u2265 2 g/dL
- Diagnosed with smoldering multiple myeloma within 5 years before starting the study drug
- Men and women of all races and ethnic groups
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky score \u2265 60%)
- Absolute neutrophil count (ANC) \u2265 1500/uL
- Hemoglobin level > 11 g/dL
- Platelet count \u2265 100,000 cells/mm\u00b3 and no recent transfusions or growth factor support within 8 weeks before screening
- Estimated creatinine clearance \u2265 30 mL/min
- Total bilirubin < 2 mg/dL except in cases of Gilbert syndrome with direct bilirubin \u2264 2 times institutional normal
- AST and ALT < 2.5 times institutional upper limit of normal
- Left ventricular ejection fraction \u2265 40%
- Females of childbearing potential must have negative pregnancy tests and agree to use effective contraception or abstinence as specified
- Male participants must agree to use adequate contraception during and for 3 months after the study
- Willingness to comply with study visits and protocol requirements
- Signed informed consent
- Prior or concurrent cancer allowed if it does not interfere with the study
You will not qualify if you...
- Multiple myeloma requiring treatment by SLiM-CRAB criteria
- Presence of MGUS, POEMS syndrome, plasma cell leukemia, AL amyloidosis, or Waldenstrom's macroglobulinemia
- Use of intravenous bisphosphonates more than once a year
- Prior or ongoing treatment for plasma cell disorders
- Active hepatitis B or C infection
- HIV infection with CD4 count < 350 or history of AIDS-related illness or certain medications
- Uncontrolled illnesses such as serious infections, severe heart failure, unstable angina, recent heart attack, or psychiatric conditions limiting compliance
- Gastrointestinal diseases affecting drug absorption
- Pregnant or breastfeeding women
- Recent use of immunosuppressive medications within 14 days, except for specified low-dose or local steroids
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
N
Nisha S. Joseph, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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