Recent Updates
Recently added Catalysts

BMS-986453

Phase 1

Relapsed and/or Refractory Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment187
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06153251A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple MyelomaPHASE1 RECRUITING 187 — — Jan 23, 2024May 2, 2030Mar 18, 202619 United States, France +2
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events (AEs)
Up to 4 years
Number of participants with serious adverse events (SAEs)
Up to 4 years
Number of participants with AEs leading to discontinuation
Up to 4 years
Number of participants with AEs leading to death
Up to 4 years
Number of participants with dose-limiting toxicities (DLTs)
Up to 4 years
Secondary Endpoints
Maximum observed concentration (Cmax)
Up to 4 years
Time of maximum observed concentration (Tmax)
Up to 4 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Up to 4 years
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Administration of BMS-986453EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986453DRUGSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease. * Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen befo...

Countries:United StatesFranceGermanySpain
Unlock Eligibility Criteria
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
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06153251primaryCompletionDate: changed
LOWMay 24, 2026NCT06153251studyFirstPostDate: changed