SUCCESSOR-1, a phase 3 trial of novel CELMoD agent mezigdomide for the treatment of RRMM1
NCT05519085A study for people with RRMM with 1-3 prior treatments including lenalidomide comparing1:
EXPERIMENTAL ARM
Mezi-Vd
mezigdomide, bortezomib, and dexamethasone
SoC OPTION ARM
Pom-Vd
pomalidomide, bortezomib, and dexamethasone
Key Inclusion Criteria1
- Adult patients who received 1-3 prior lines of anti-myeloma therapy with progressive disease
- Prior treatment with a lenalidomide-containing regimen
- Minimal response or better to at least 1 prior therapy
Key Exclusion Criteria1
- Patients with prior mezigdomide or pomalidomide exposure
- Patients with PI refractoriness (except to bortezomib maintenance, dosed no more frequently than Q2W)
SUCCESSOR-1 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 enrolled in stage 1 on a dose of Mezi 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)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); Q2W=once every 2 weeks; R=REVLIMID® (lenalidomide); RRMM=relapsed/refractory multiple myeloma; SCT=stem cell transplant; V=Velcade® (bortezomib).
References: 1. Richardson PG, Badelita S, Besemer B, et al. A phase 3, two-stage, randomized study of mezigdomide, bortezomib, and dexamethasone versus pomalidomide, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: SUCCESSOR-1. Poster presented at: 11th Annual Meeting of the Society for Hematologic Oncology (SOHO); September 6-9, 2023; Houston, TX. 2. A phase 3, two-stage, randomized, multicenter, open-label study comparing mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-1. ClinicalTrials.gov identifier: NCT05519085. Updated October 27, 2023. Accessed October 31, 2023. https://clinicaltrials.gov/study/NCT05519085