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Official Title
Iberdomide in Intermediate- and High-Risk Smoldering Myeloma (SMM) Patients: A Phase 2 Study With a Safety Run-in
Phase
Phase 2
Sponsor
Emory University
Enrollment
68
Timeline
Nov 2021 → Sep 2029
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.
Eligibility Criteria
Inclusion Criteria
- 1Subject 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:
- 2Bone marrow clonal plasma cells \>= 20% confirmed on either screening bone marrow biopsy or by outside pathology ≤5 years from initiation of study drug.
- 3Abnormal serum free light chain ratio \> 20 by serum free light chain (FLC) assay
- 4Serum monoclonal protein \>= 2 g/dL
- 5Subject must have been diagnosed with SMM =\< 5 years from initiation of study drug
- 6Both men and women of all races and ethnic groups are eligible for this study
- 7Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \>= 60%) is required for eligibility
- 8Absolute neutrophil count (ANC) \>= 1500/uL
- 9Hemoglobin (Hgb) \> 11 g/dL
- 10Platelet 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
- 11Estimated creatinine clearance \>= 30 mL/min as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockcroft-Gault
- 12Total 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
- 13Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the institutional upper limit of normal
- 14Left ventricular ejection fraction \>= 40%
- 15Females 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
- 16Female of childbearing potential (FCBP) is a sexually mature woman who:
- 17Has not undergone a hysterectomy or bilateral oophorectomy; or
- 18Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- 19The subject must be willing to comply with fertility requirements as below:
- 20Male subjects must agree to use an adequate method of contraception for the duration of the study and for 3 months afterwards
- 21Female 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
- 22Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 4 weeks after stopping treatment
- 23Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted
- 24Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- 25Subjects 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 Criteria
- 1Multiple myeloma requiring treatment as defined by SLiM-CRAB criteria
- 2Monoclonal 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
- 3Concurrent intravenous bisphosphonate use more often than once a year
- 4Prior or ongoing treatment for plasma cell disorder
- 5Active hepatitis B or C due to risk of infection made worse by study drug
- 6If 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
- 7Subjects 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
- 8Uncontrolled 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
- 9Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide
- 10Pregnant 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
- 11Current 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)
Locations
1 site participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Nisha S. Joseph, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →