Iberdomide in Intermediate- and High-Risk Smoldering Myeloma (SMM) Patients: A Phase 2 Study With a Safety Run-in
Emory University
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.
Description
PRIMARY OBJECTIVE: I. To determine the overall response rate (ORR) of iberdomide hydrochloride (iberdomide) and iberdomide with dexamethasone in intermediate- and high-risk smoldering multiple myeloma (SMM). SECONDARY OBJECTIVES: I. To determine the 1- and 2- year progression free survival rates of patients receiving iberdomide with and without dexamethasone in intermediate-risk and high-risk smoldering myeloma. II. To determine the time to progression, and overall survival of patients with intermediate- and high-risk smoldering myeloma receiving iberdomide with and without dexamethasone.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
Interventions
- DrugDexamethasone
Given PO
- DrugIberdomide Hydrochloride
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
Location
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia