Analysis of real-world outcomes of Australian newly diagnosed multiple myeloma (NDMM) patients from the Myeloma and Related Disease Registry (MRDR) shows that 20-25% of all NDMM cases relapse within 12 months of starting first-line (1L) treatment. We categorise this as functional high-risk. These early progressors have significantly lower overall survival. Currently available PBS treatments do not address this unmet need, and ASCT is not an effective salvage therapy.
Iberdomide (Iber) is a CELMoD, a next-generation immunomodulatory imie drug (IMiD), that is more potent than lenalidomide or pomalidomide. Isatuximab (Isa) is an anti-CD38 monoclonal antibody and has been used in the ICARIA-MM with pomalidomide and dexamethasone (Dex) and showed increase in survival.
The IBIS study will explore the use of the Iber-IsaDex triplet in treating functional high-risk MM patients -- patients who relapse within 12 months of starting first-line therapy. The IBIS study will assess efficacy and safety of Iber-IsaDex, overall survival, and patient-reported outcomes. We will also be conducting correlative studies in parallel.
Prospective, multicentre, open-label trial, phase II study
Blood, bone marrow and saliva samples will be collected as part of the trial to assess the immunological, epigenetics and molecular profile.
TRIAL PRINCIPAL INVESTIGATORS
Professor Andrew Spencer, Dr Sueh-li Lim
2022 – 2027
Patients who demonstrate disease progression within 12 months of commencing first-line (1L) and/or primary refractoriness to induction therapy.
Alfred Hospital, VIC