SUCCESSOR-2, a phase 3 trial of novel CELMoD agent mezigdomide for the treatment of RRMM1
NCT05552976SUCCESSOR-2 is a phase 3, two-stage, randomized, multicenter, open-label study of people with RRMM comparing1:
Mezi-Kd
mezigdomide, carfilzomib, and dexamethasone
Kd
carfilzomib and dexamethasone
Key Inclusion Criteria1
- Adult patients who received ≥1 prior lines of anti-myeloma therapy with progressive disease
- Prior treatment with lenalidomide and an anti-CD38 monoclonal antibody
- Minimal response or better to at least 1 prior therapy
Key Exclusion Criteria1
- Patients with prior mezigdomide or carfilzomib exposure
- Patient has previously received allogenic SCT at any time or received autologous SCT within 12 weeks of initiating study treatment
SUCCESSOR-2 Trial Schema1
A phase 3, two-stage adaptive trial in which the optimal dose is selected from stage 1 and adapted into stage 2
*Patients entrolled in stage 1 on a dose of mezidomide that is not chosen for stage 2 will have the possiblity to move to that dose if some criteria are met.
Primary Endpoint:
Progression-free survival (PFS)1
Select Secondary Endpoints:
- Overall response rate (ORR)1
- Complete response rate (CRR)2
- Overall survival (OS)1
- Minimal residual disease (MRD) negativity rate1
- Safety1
- Health-related quality of life (HRQoL)1
For further details on this trial, visit ClinicalTrials.gov
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Find the right phase 3 novel CELMoD trial for your patient
Confirm EligibilityCELMoD=cereblon E3 ligase modulator; D=Darzalex® (daratumumab); d=dexamethasone; Iber=iberdomide; K=Kyprolis® (carfilzomib); mAb: monoclonal antibody; Mezi=mezigdomide; NDMM=newly diagnosed multiple myeloma; Pom=POMALYST® (pomalidomide); REVLIMID® (lenalidomide); RRMM=relapsed/refractory multiple myeloma; SCT=stem cell transplant; V=Velcade® (bortezomib).
References: 1. Richardson PG, Amatangelo M, Berenson JR, et al. A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma: SUCCESSOR-2. Poster presented at: Annual Meeting of the American Society of Clinical Oncology (ASCO); June 2-6, 2023; Chicago, IL. 2. A phase 3, two-stage, randomized, multicenter, open-label study comparing mezigdomide (CC-92480/BMS-986348), carfilzomib and dexamethasone (MeziKD) versus carfilzomib and dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-2. ClinicalTrials.gov identifier: NCT05552976. Updated October 31, 2023. Accessed October 31, 2023. https://clinicaltrials.gov/study/NCT05552976