Iberdomide with or without Dexamethasone for Smoldering Multiple Myeloma
This study is looking at how well iberdomide, alone or combined with dexamethasone, works for people with intermediate- or high-risk smoldering multiple myeloma (SMM). Iberdomide is an immunotherapy, meaning it may help your body's immune system fight cancer cells. Dexamethasone is a steroid often used with other cancer treatments. Researchers want to see if combining these drugs can improve how long it takes for SMM to worsen into active myeloma, while also being well-tolerated. The main goal is to see how many patients respond to the treatment. You may be eligible if you are 18 or older and have intermediate- or high-risk SMM, confirmed by at least 20% plasma cells in your bone marrow.
- Study design
- This study is an interventional trial with a planned enrollment of 68 participants. It is testing iberdomide alone or in combination with dexamethasone.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure overall response rate for up to 3 years, and will also look at progression-free survival and overall survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04776395
Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
Recruiting
PHASE2Ages 18+InterventionalTreatmentEmory UniversityInvestigator-initiated
~68 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:DexamethasoneIberdomide HydrochlorideQuality-of-Life Assessment
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate
Measured over Up to 3 years
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Nisha S Joseph, MD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Hemoglobin (Hgb) \> 11 g/dL
Platelet count \>= 100,000 cells/mm\^3 and must be platelet and packed red blood cells (PRBC) transfusion independent with no granulocyte colony-stimulating factor (G-CSF) to ensure eligibility within 8 weeks of screening
Estimated creatinine clearance \>= 30 mL/min as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockcroft-Gault
Total bilirubin \< 2 mg/dL except in subjects with congenital bilirubinemia such as Gilbert syndrome, in which case direct bilirubin =\< 2 times the institutional upper limit of normal is required
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the institutional upper limit of normal
Left ventricular ejection fraction \>= 40%
Females of childbearing potential (FCBP) must have two negative pregnancy tests as verified by the investigator prior to starting study treatment. The effects of Iberdomide on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. A FCBP must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of iberdomide. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female of childbearing potential (FCBP) is a sexually mature woman who:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
The subject must be willing to comply with fertility requirements as below:
Male subjects must agree to use an adequate method of contraception for the duration of the study and for 3 months afterwards
Female subjects must be either postmenopausal, free from menses \>= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening and for 3 months after last treatment in all patients
Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 4 weeks after stopping treatment
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted
Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Exclusion
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
Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide
Pregnant women are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to protocol treatment of the mother, breastfeeding should be discontinued
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of iberdomide. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or equivalent steroids as premedication for hypersensitivity reactions (e.g, computed tomography \[CT\] scan pre-medications)
What this trial measures
- Overall response rateUp to 3 years
Assessed per International Myeloma Working Group response criteria (to be done with serum and urine immunologic studies monthly; bone marrow biopsy and repeat imaging at either complete response or progressive disease).