EXCALIBER Maintenance, a phase 3 trial of novel CELMoD agent iberdomide for the treatment of NDMM1
NCT05827016EXCALIBER Maintenance is a randomized, phase 3 head-to-head study of people with NDMM that is designed to investigate post-SCT treatment with1:
Iberdomide
REVLIMID®
(lenalidomide)
Key Inclusion Criteria
- Patients who received 3-6 cycles of induction therapy that includes a proteasome inhibitor and an immunomodulatory drug or VCd followed by a single or tandem ASCT1
- Patients who achieve a ≥PR after ASCT within 12 months of initiation of induction therapy1,2
Key Exclusion Criteria
- Patients with progressive disease or clinical relapse following ASCT or not responsive to primary therapy1
- Patients with smoldering myeloma, solitary plasmacytoma, or nonsecretory myeloma1
EXCALIBER Maintenance Trial Schema1
A phase 3, two-stage adaptive trial in which the optimal dose is selected from stage 1 and adapted into stage 2
Primary Endpoints1:
Progression-free survival (PFS)
Select Secondary Endpoints1:
- Safety
- Health-related quality of life (HRQoL)
- Minimal residual disease (MRD) negativity in patients with ≥CR at 12 months of maintenance treatment
- Time to progression
- Overall survival (OS)
For further details on this trial, visit ClinicalTrials.gov
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Confirm EligibilityASCT=autologous stem cell transplant; CELMoD=cereblon E3 ligase modulator; CR=complete response; D=Darzalex® (daratumumab); d=dexamethasone; Iber=iberdomide; K=Kyprolis® (carfilzomib); mAb=monoclonal antibody; Mezi=mezigdomide; NCT=National Clinical Trial; NDMM=newly diagnosed multiple myeloma; Pom=POMALYST® (pomalidomide); PR=partial response; R=REVLIMID® (lenalidomide); RRMM=relapsed/refractory multiple myeloma; SCT=stem cell transplant; SoC=standard of care; V=Velcade® (bortezomib).
References: 1. Gay F, Dimopoulos MA, Huang X, et al. A phase 3, two-stage, randomized study of iberdomide, maintenance versus lenalidomide maintenance post autologous stem cell transplantation in newly diagnosed multiple myeloma: EXCALIBER-Maintenance. Poster presented at: 20th Annual Meeting of the International Myeloma Society (IMS); September 27-30, 2023; Athens, Greece. 2. A phase 3, two-stage, randomized, multicenter, controlled, open-label study comparing iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplant (ASCT) in participants with newly diagnosed multiple myeloma (NDMM) (EXCALIBER-Maintenance). ClinicalTrials.gov identifier: NCT05827016. Updated October 26, 2023. Accessed October 31, 2023. https://www.clinicaltrials.gov/study/NCT05827016