Actively Recruiting
Iberdomide Alone or With Dexamethasone for Intermediate- or High-Risk Smoldering Multiple Myeloma: A Phase 2 Study
Led by Emory University · Updated on 2026-06-01
68
Participants Needed
1
Research Sites
104 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
Researchers are evaluating the effects of iberdomide alone or combined with dexamethasone in patients with intermediate- or high-risk smoldering multiple myeloma, a condition where abnormal plasma cells are present but symptoms have not yet developed. This phase II study aims to understand how these treatments may impact the immune system and potentially slow the progression to symptomatic myeloma while monitoring their safety and tolerability. Participants are randomly assigned to one of two groups. One group receives oral iberdomide daily on days 1 to 21 of a 28-day cycle along with dexamethasone on days 1, 8, 15, and 22 for four cycles, followed by iberdomide alone in the same dosing schedule. The other group receives only oral iberdomide daily on days 1 to 21 of each 28-day cycle. Treatments continue unless the disease progresses or side effects become unacceptable. During the study, participants undergo regular assessments to track their response to treatment, including overall response rate, progression-free survival, time to disease progression, and overall survival. Safety is monitored by recording adverse events, and specific tests evaluate blood cell counts, organ function, and stem cell mobilization. After the treatment period, patients have a follow-up visit four weeks later and then every six months to monitor their health and disease status.
CONDITIONS
Brief 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...
- Diagnosed with intermediate- or high-risk smoldering multiple myeloma confirmed by bone marrow plasma cells ≥ 20%, abnormal serum free light chain ratio > 20, or serum monoclonal protein ≥ 2 g/dL
- Diagnosis made within 5 years before starting study drug
- Age 18 years or older, any gender or race
- ECOG performance status 0 to 2 (Karnofsky ≥ 60%)
- Absolute neutrophil count ≥ 1500/uL
- Hemoglobin > 11 g/dL
- Platelet count ≥ 100,000 cells/mm³, transfusion independent, no G-CSF within 8 weeks
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin < 2 mg/dL (exceptions for congenital bilirubinemia)
- AST and ALT < 2.5 times institutional upper limit
- Left ventricular ejection fraction ≥ 40%
- Females of childbearing potential must have negative pregnancy tests and agree to contraception or abstinence
- Males must agree to contraception during study and for 3 months after
- Agree not to donate blood or reproductive cells during treatment and 4 weeks after
- Able and willing to comply with study visits and procedures
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
You will not qualify if you...
- Multiple myeloma requiring treatment by SLiM-CRAB criteria
- Other plasma cell disorders like MGUS, POEMS syndrome, plasma cell leukemia, AL amyloidosis, Waldenstroms macroglobulinemia
- Intravenous bisphosphonate use more than once a year
- Prior or ongoing treatment for plasma cell disorders
- Active hepatitis B or C infection
- HIV with CD4 count below 350, AIDS-related illness history, or on certain HIV medications
- Uncontrolled illness including infections, severe heart failure, unstable angina, recent heart attack, or psychiatric/social issues
- Gastrointestinal diseases affecting iberdomide absorption
- Pregnant or breastfeeding women
- Use of immunosuppressive medications within 14 days before first dose, except certain steroids for allergy or local use
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 - Up to approximately 3 years depending on disease progression or toxicity
Participants receive iberdomide hydrochloride orally once daily on days 1-21 in 28-day cycles. Participants in Arm A also receive dexamethasone orally on days 1, 8, 15, and 22 for the first 4 cycles. Treatment continues in cycles until disease progression or unacceptable toxicity.
Monthly visits for treatment cycles
Duration - 4 weeks, then every 6 months thereafter
After completing treatment, participants are followed up to monitor health and outcomes.
1 visit 4 weeks after treatment, then visits every 6 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here