A Phase 1b/2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant
Dana-Farber Cancer Institute
Summary
This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant. The names of the study drugs used in this research study are: isatuximab, iberdomide, bortezomib dexamethasone
Description
This is an open-label, Phase 1b/2, multicenter study which will enroll patients with newly diagnosed multiple myeloma (NDMM), who are transplant ineligible or deferred, to induction followed by maintenance therapy. Participants will be registered in HCC CTMS OnCore before receiving any study-specific treatment, and study treatment is expected to begin within 5 days after registration. The study drugs used in this research include bortezomib, dexamethasone, isatuximab, and iberdomide (CC-220). The U.S. Food and Drug Administration (FDA) has approved bortezomib and dexamethasone for the initial…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, 18 years of age or older * Ability to understand and the willingness to sign a written informed consent document * NDMM based on IMWG criteria with clonal bone marrow plasma cells \>10% or biopsy proven bony or extramedullary disease/plasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024). (See Appendix G) * Ineligible for ASCT as assessed by the treating physician or eligible but prefers and agrees to defer ASCT until after induction and maintenance therapy, upon progression or at a later time * Measurable diseas…
Interventions
- DrugIsatuximab
Administration, pre-medications and supportive care per protocol
- DrugIberdomide
Administration, pre-medications and supportive care per protocol
- DrugBortezomib
Administration, pre-medications and supportive care per protocol
- DrugDexamethesone
Administration, pre-medications and supportive care per protocol
Locations (2)
- Beth Israel Deaconess Medical Center (BIDMC)Boston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts