Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Emory University
You may qualify if…
- ✓ Subject must have intermediate- or high risk smoldering multiple myeloma (SMM) as confirmed by at least one of the following factors either at screening or within 28 days of screening:
- ✓ Bone marrow clonal plasma cells \>= 20% confirmed on either screening bone marrow biopsy or by outside pathology ≤5 years from initiation of study drug.
- ✓ Abnormal serum free light chain ratio \> 20 by serum free light chain (FLC) assay
- ✓ Serum monoclonal protein \>= 2 g/dL
- ✓ Subject must have been diagnosed with SMM =\< 5 years from initiation of study drug
- ✓ Both men and women of all races and ethnic groups are eligible for this study
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \>= 60%) is required for eligibility
- ✓ Absolute neutrophil count (ANC) \>= 1500/uL
You may not qualify if…
- ✕ Multiple myeloma requiring treatment as defined by SLiM-CRAB criteria
- ✕ Monoclonal gammopathy of undetermined significance (MGUS), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS syndrome), plasma cell leukemia, primary systemic light chain (AL) amyloidosis, or Waldenstroms macroglobulinemia
- ✕ Concurrent intravenous bisphosphonate use more often than once a year
- ✕ Prior or ongoing treatment for plasma cell disorder
- ✕ Active hepatitis B or C due to risk of infection made worse by study drug
- ✕ If subject has human immunodeficiency virus (HIV), they must have a CD4 count \>= 350, no history of acquired immune deficiency syndrome-related illness, and not currently prescribed zidovudine or stavudine
- ✕ Subjects may be receiving concomitant low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions
- ✕ Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
Where it's recruiting
Atlanta
Source: ClinicalTrials.gov · NCT04776395 · last updated 2026-06-01