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
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
Corticosteroids for management of MM not to exceed equivalent of 160 mg of dexamethasone in a 2-week period and should be stable 7 days prior to the registration.
Focal palliative radiation for the management of bone pain completed ≥ 7 days prior to registration
Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity.
Resolution of symptoms of prior treatment to ≤ grade 1 or baseline
Parallel
Isatuximab
DrugAdministration, pre-medications and supportive care per protocol
Iberdomide
DrugAdministration, pre-medications and supportive care per protocol
Bortezomib
DrugAdministration, pre-medications and supportive care per protocol
Dexamethesone
DrugAdministration, pre-medications and supportive care per protocol
6
Treatment groupsSee each treatment group below.
Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]
DLT is defined as any adverse event (AE) that (a) is at least possibly related to study treatment, (b) occur during cycle 1, and (c) meets the following criteria: Hematologic - grade 4 neutropenia lasting \>5 days despite supportive care (G-CSF allowed), grade ≥3 febrile neutropenia, grade 3 thrombocytopenia with clinically significant bleeding, grade 4 thrombocytopenia unless clearly attributable to underlying disease, and any grade 5 AE; Non-Hematologic - any grade ≥3 AE (except alopecia), uncontrolled nausea, vomiting, or diarrhea not resolving to ≤ grade 1 with medical management, due to toxicity interruption of \>4 doses of iberdomide or \>1 dose of isatuximab or bortezomib (infusion-related reactions excluded), due to toxicity inability to initiate cycle 2 day 1 within 7 days.
Recommended Phase II Dose (RP2D) of Iberdomide by Age-Frailty Group [Phase Ib]
The RP2D of iberdomide in combination with fixed doses of isatuximab, bortezomib and dexamethasone is determined by the number of participants experiencing DLT. There are two potential iberdomide dose levels under evaluation including one de-escalation dose. The RP2D is defined as the highest dose at which fewer than 2 of 6 patients experience a DLT.
Complete Response (CR) or Better Rate by Age-Frailty Group [Phase II]
CR or better rate is defined as the proportion of participants who achieve a complete response (CR) or stringent CR (sCR) during induction therapy, according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC).
Induction Grade 3 or 4 Treatment-Related Adverse Event (TRAE) Rate by Age-Frailty Group [Phase Ib]
Induction grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on Common Toxicity Criteria for Adverse Events version 5 (CTCAEv5) with a treatment attribution of possible, probable or definite during induction.
Induction Best Response by Age-Frailty Group [Phase II]
Best response over induction will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.
Maintenance Best Response by Age-Frailty Risk Group [Phase II]
Best response over maintenance will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.
Induction Minimal Residual Disease (MRD) Negativity Rate by Age-Frailty Group [Phase II]
Induction MRD-negative rate is defined as the proportion of participants achieving MRD negativity, as assessed by next-generation sequencing (NGS) or next-generation flow cytometry (NGF) with sensitivity of \>1 in 10-5 nucleated cells, according to the IMWG-URC.
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