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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disease defined as at least one of the following:
* Serum M-protein 0.5 g/dL
* Urine M-protein 200 mg/24 hours
* Serum FLC assay: involved FLC 10 mg/dL (100 mg/L) and an abnormal kappa to lambda FLC ratio (\< 0.26 or \> 1.65)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix A)
* Screening Laboratory evaluations with the following parameters:
* Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L)
\--- Note: Growth factor support is not permitted within 10 days, \[14 days for pegfilgrastim\], prior to the screening hematologic test.
* Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions required during the 3 days prior to the screening hematologic test)
* Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* AST (SGOT) and ALT (SGPT) ≤ 3.0…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]
Timeframe: Assessed continuously during induction cycle 1, up to day 28 + 30 days
2
Recommended Phase II Dose (RP2D) of Iberdomide by Age-Frailty Group [Phase Ib]
Timeframe: Assessed continuously during induction cycle 1, up to day 28 + 30 days
3
Complete Response (CR) or Better Rate by Age-Frailty Group [Phase II]
Timeframe: Assessed on day 1 of each cycle over 8 induction cycles (cycle duration=4 weeks), up to 32 weeks.