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Mezigdomide

Phase 3

Relapsed or Refractory Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,416
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05552976A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)PHASE3 ACTIVE NOT_RECRUITING 606Jan 10, 2023Jul 25, 2029Apr 1, 2026207 United States, Argentina +25
NCT05519085A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)PHASE3 RECRUITING 810Sep 20, 2022Nov 30, 2033Jun 3, 2026266 United States, Argentina +27
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Study Endpoints
Primary Endpoints
Progression-free Survival (PFS)
Up to approximately 5 years
Secondary Endpoints
Recommended Mezigdomide Dose
Up to 12 months
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Up to 176 days
Overall Survival (OS)
Up to approximately 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)EXPERIMENTAL -
Kd (Carfilzomib + Dexamethasone)ACTIVE_COMPARATOR -
MeziVd (mezigdomide, bortezomib and dexamethasone)EXPERIMENTAL -
PVd (pomalidomide, bortezomib and dexamethasone)EXPERIMENTAL -
Interventions
NameTypeDescription
MezigdomideDRUGSpecified dose on specified days
CarfilzomibDRUGSpecified dose on specified days
DexamethasoneDRUGSpecified dose on specified days
PomalidomideDRUGSpecified dose on specified days
BortezomibDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites207

Inclusion Criteria \- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or. ii) M-protein ≥ 200 milligrams (mg)/24-hour urine colle...

Countries:United StatesArgentinaAustraliaAustriaBrazilBulgariaCanadaChinaColombiaDenmarkGermanyGreeceHong KongHungaryIndiaIsraelItalyJapanNetherlandsNorwayPuerto RicoRomaniaSingaporeSouth KoreaSpainTaiwanUnited KingdomBelgiumChileCzechiaFinlandFranceIrelandNew ZealandPolandPortugalSouth AfricaTurkey (Türkiye)
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Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT05519085lastUpdatePostDate: changed
LOWJun 4, 2026NCT05519085lastUpdatePostDate: changed
LOWJun 4, 2026NCT05519085lastUpdatePostDate: changed
LOWJun 4, 2026NCT05519085lastUpdatePostDate: changed
LOWJun 4, 2026NCT05519085lastUpdatePostDate: changed
LOWMay 28, 2026NCT05519085lastUpdatePostDate: changed
LOWMay 28, 2026NCT05519085lastUpdatePostDate: changed
LOWMay 26, 2026NCT05519085primaryCompletionDate: changed
LOWMay 26, 2026NCT05552976Enrollment: 525 → 606
LOWMay 24, 2026NCT05519085studyFirstPostDate: changed
LOWMay 24, 2026NCT05552976studyFirstPostDate: changed