EXCALIBER RRMM, a phase 3 trial of novel CELMoD agent iberdomide for the treatment of RRMM
NCT04975997EXCALIBER RRMM is a phase 3, two-stage, randomized, multicenter, open-label study of people with RRMM comparing:
Iber-Dd
iberdomide, daratumumab, and dexamethasone
DVd
daratumumab, bortezomib, and dexamethasone
Key Inclusion Criteria
- Adult patients who received 1-2 prior lines of anti-myeloma therapy and have progressive disease
Key Exclusion Criteria
- Patients who are refractory to bortezomib or an anti-CD38 monoclonal antibody
- Patients with prior anti-CD38 exposure; some exceptions apply in stage 2
EXCALIBER RRMM Trial Schema
A phase 3, two-stage adaptive trial in which the optimal dose is selected from stage 1 and adapted into stage 2
*Patients enrolled in stage 1 on a dose of Iber that is not chosen for stage 2 will have the possibility to move to that dose if some criteria are met.
Primary Endpoint:
Progression-free survival (PFS)
Select Secondary Endpoints:
- Overall response rate (ORR)
- Minimal residual disease negativity rate (MRD neg)
- Overall survival (OS)
- Health-related quality of life (HRQoL)
- Safety
For further details on this trial, visit ClinicalTrials.gov
Find a clinical trial location
Enroll a patient or find out how to register your clinic as a trial site
First line of the email MUST contain the NCT # and Site #
Available 24/7
Explore More Novel CELMoD Trials
Iberdomide phase 3 study
Mezigdomide phase 3 studies
- Mezi-Vd vs Pom-Vd
- Patients with RRMM and 1-3 priors with lenalidomide exposure
- Mezi-Kd vs Kd
- Patients with RRMM and ≥1 priors with lenalidomide and anti-CD38 mAb exposure
Find the right phase 3 novel CELMoD trial for your patient
Confirm EligibilityCELMoD=cereblon E3 ligase modulator; D=Darzalex® (daratumumab); d=dexamethasone; IA=interim analysis; Iber=iberdomide; K=Kyprolis® (carfilzomib); mAb=monoclonal antibody; Mezi=mezigdomide; NDMM=newly diagnosed multiple myeloma; Pom=POMALYST® (pomalidomide); RRMM=relapsed/refractory multiple myeloma; SCT=stem cell transplant; V=Velcade® (bortezomib).
Reference: Lonial S, Quach H, Dimopoulos MA, et al. EXCALIBER-RRMM: a phase 3, two-stage study of iberdomide, daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma. Poster presented at: Annual Meeting of the American Society of Clinical Oncology (ASCO); June 2-6, 2023; Chicago, IL.