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.
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
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
Parallel
Dexamethasone
DrugGiven PO
Iberdomide Hydrochloride
DrugGiven PO
Quality-of-Life Assessment
Other interventionAncillary studies
Overall response rate
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).
Progression-free survival
Will be estimated with the Kaplan-Meier method with 95% confidence interval (CI) for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported.
Time to progression
Will be estimated with the Kaplan-Meier method with 95% CI for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported.
Overall survival
Will be estimated with the Kaplan-Meier method with 95% CI for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported.
Rate of grade 3-4 adverse events
Adverse event data will be described and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events guidelines. Grade 3-4 adverse events will be estimated as frequency and percentage, and then compared between the two patient groups using Chi-Square test.
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Emory University
Lead sponsor
Bristol-Myers Squibb
Collaborator
National Cancer Institute (NCI)
Collaborator
