About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dexamethasone
- Iberdomide Hydrochloride
- Quality-of-Life Assessment
Treatment groups
Sponsors and collaborators
Emory University
Lead sponsor
Bristol-Myers Squibb
Collaborator
National Cancer Institute (NCI)
Collaborator