Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

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

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Bristol-Myers Squibb

Collaborator

National Cancer Institute (NCI)

Collaborator