Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-… (NCT04776395) | Clinical Trial Compass
RecruitingPhase 2
Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
United States68 participantsStarted 2021-07-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 i…