Table of contents
- Overview of the Iberdomide trials
- Who the trials are for
- Trial phases and what they mean
- Main outcomes being measured
- Key studies and treatment combinations
- What the trial program shows overall
Overview of the Iberdomide trials
The available studies are testing Iberdomide in people with multiple myeloma, which is a cancer of plasma cells in the bone marrow.[1] The trials include newly diagnosed disease, first relapse in older patients, and relapsed or refractory disease, meaning cancer that has returned or is not responding well to treatment.[1]
Most studies are interventional trials, which means the researchers assign a treatment plan and then measure the results.[1] The trial program includes both single-drug and combination approaches, so Iberdomide is being studied with other myeloma treatments such as dexamethasone, daratumumab, ixazomib, cyclophosphamide, isatuximab, bortezomib, carfilzomib, cevostamab, and etentamig.[1]
Who the trials are for
The studies are designed for adults with multiple myeloma in different stages of treatment.[1] Some trials focus on elderly patients at first relapse, some on transplant-ineligible newly diagnosed patients, and others on patients after autologous stem cell transplant (ASCT), which uses the patient’s own stem cells after intensive treatment.[1]
Several studies are for relapsed/refractory multiple myeloma (RRMM), a term used when the disease comes back or does not respond as expected.[1] Other studies are for newly diagnosed patients who are candidates for transplant or who are already in maintenance treatment after transplant.[1]
Trial phases and what they mean
Phase 1 studies are mainly about safety, tolerability, and dose finding.[1] In the Iberdomide program, Phase 1 trials look at dose-limiting toxicities, maximum tolerated dose, and recommended Phase 2 dose for different combinations.[1]
Phase 2 studies are designed to learn more about how well the treatment works and to continue safety checks.[1] The Phase 2 trials with Iberdomide measure response rates, progression-free survival, and response improvement after transplant or in relapse settings.[1]
Phase 3 studies are larger and compare treatment strategies to see which works better.[1] The Phase 3 Iberdomide trials compare maintenance strategies, treatment combinations, and response outcomes such as MRD negativity and progression-free survival.[1]
Main outcomes being measured
The most common outcome is progression-free survival (PFS), which means the time until the cancer gets worse or the patient dies from any cause.[1] This outcome is used in the ICON study, the RRMM comparison study, and the maintenance comparison after transplant in NDMM.[1]
Another important outcome is minimal residual disease (MRD) negativity, which means no detectable cancer cells using very sensitive tests.[1] Several studies measure MRD negativity after treatment, after maintenance, or after transplant because it can show how deep the response is.[1]
Other outcomes include overall response rate (ORR), very good partial response (VGPR), complete response (CR), stringent complete response (sCR), overall survival (OS), and dose-limiting toxicities (DLTs).[1] These terms help researchers see whether the treatment is working, how strong the response is, and whether side effects limit the dose that can be given.[1]
Key studies and treatment combinations
The Phase 2 study NCT04998786 is testing Iberdomide with ixazomib and dexamethasone in elderly patients at first relapse, and its main goal is the rate of VGPR or better.[1] This study is authorised and plans to enroll 80 participants.[1]
The ICON study, NCT04392037, is a Phase 2 trial in relapsed/refractory multiple myeloma that evaluates Iberdomide with low-dose cyclophosphamide and dexamethasone.[1] Its main endpoint is progression-free survival, and it plans to enroll 60 participants.[1]
The Phase 1 study 2024-512146-41-00 tests etentamig with Iberdomide in relapsed/refractory multiple myeloma, with a focus on dose-limiting toxicities and finding the right doses for the combination.[1] It is authorised and plans to enroll 135 participants.[1]
The large Phase 1 dose-finding study 2024-510799-19-00 examines Iberdomide alone and in several combinations, including with dexamethasone, daratumumab, bortezomib, and carfilzomib, in multiple myeloma.[1] It aims to find the maximum tolerated dose or recommended Phase 2 dose and also looks at overall response rate in one cohort.[1]
The Phase 3 trial NCT04934475 is a major study of minimal residual disease adapted strategy in multiple myeloma, where Iberdomide appears in one of the treatment arms.[1] Its main goal is to compare MRD negativity before maintenance in different treatment strategies, and it plans to enroll 791 participants.[1]
The Phase 3 study 2024-510800-35-00 compares Iberdomide, daratumumab, and dexamethasone against daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma.[1] It measures progression-free survival and MRD-negative complete response, and it is one of the largest trials in the set with 864 planned participants.[1]
Other important studies include the Phase 2 trial 2024-518870-15-00 in transplant-ineligible newly diagnosed patients, the Phase 3 maintenance trial 2023-507402-13-00 after ASCT, the Phase 2 maintenance study NCT04564703, and the Phase 3 maintenance comparison 2022-501515-14-00 versus lenalidomide after ASCT.[1] These studies show that Iberdomide is being tested both as early treatment and as long-term maintenance therapy.[1]
What the trial program shows overall
Across the trial program, Iberdomide is being studied in several settings, not just one stage of disease.[1] Researchers are trying to learn whether it can help patients reach deeper responses, stay in remission longer, and improve outcomes after transplant or in relapse.[1]
The studies also show that Iberdomide is often being tested in combination with other medicines rather than alone.[1] This helps researchers understand which treatment mix may work best for different patient groups with multiple myeloma.[1]
