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AMaRC 20-01 - STUDY TITLE: An immuno-therapeutic salvage strategy for 'functional' high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab and Dexamethasone (IBIS)

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.
 

STATUS

Actively recruiting

 

CURRENT ENROLMENT

24 Patients

Recruitment updated as of June 2024

 

STUDY DESIGN

Prospective, multicentre, open-label trial, phase II study 

 

CORRELATIVE STUDIES

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

 

TIME FRAME

2022 – 2027

 

PARTICIPANTS

Patients who demonstrate disease progression within 12 months of commencing first-line (1L) and/or primary refractoriness to induction therapy. 

 

SITE LOCATIONS