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BMS-986393

Phase 3

Relapsed or Refractory Multiple Myeloma (RRMM) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 18, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment440

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986393 · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT06615479A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)Relapsed or Refractory Multiple Myeloma (RRMM)
RECRUITING440 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
Relapsed or Refractory Multiple Myeloma (RRMM)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Up to 1 year after the last participant is randomized
Incidence of adverse events (AEs)
Up to 2 years
Incidence of serious adverse events (SAEs)
Up to 2 years
Incidence of adverse events of special interest (AESI)
Up to 2 years
Incidence of AEs leading to discontinuation
Up to 2 years
Number of Deaths
Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Up to 2 years

Secondary Endpoints

Overall survival (OS)
Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Up to 5 years after the last participant is randomized
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm A: BMS-986393 + AlnuctamabEXPERIMENTAL -
Arm B: BMS-986393 + MezigdomideEXPERIMENTAL -
Arm C: BMS-986393 + IberdomideEXPERIMENTAL -
Arm D: BMS-986393 + ElranatamabEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986393DRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
DaratumumabDRUGSpecified dose on specified days
PomalidomideDRUGSpecified dose on specified days
DexamethasoneDRUGSpecified dose on specified days
CarfilzomibDRUGSpecified dose on specified days
AlnuctamabDRUGSpecified dose on specified days
MezigdomideDRUGSpecified dose on specified days
IberdomideDRUGSpecified dose on specified days
ElranatamabDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites141

Inclusion Criteria * Participants must have relapsed or refractory multiple myeloma (RRMM). * Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monocl...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIsraelItalyJapanNetherlandsNorwayPolandPortugalRomaniaSaudi ArabiaSingaporeSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed or Refractory Multiple Myeloma (RRMM)")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, 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
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
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
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Recent Changes (Last 90 Days)

LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed
LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed
LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed
LOWJul 24, 2026NCT06615479lastUpdatePostDate: changed
LOWJul 24, 2026NCT06615479lastUpdatePostDate: changed
LOWJun 26, 2026NCT06615479lastUpdatePostDate: changed
LOWJun 26, 2026NCT06615479lastUpdatePostDate: changed

Frequently asked questions about BMS-986393

What is BMS-986393 used for?

BMS-986393 is an investigational therapy being studied for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma (RRMM). It is being evaluated in clinical trials for adult participants with this blood cancer.

Who makes BMS-986393?

BMS-986393 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in multiple myeloma.

What phase is BMS-986393 in?

BMS-986393 is in clinical development, with trials in Phase 1 and Phase 3. The Phase 1 trial is studying the drug in novel combinations, while the Phase 3 trial, called QUINTESSENTIAL-2, compares it to standard regimens in relapsed or refractory multiple myeloma.

What clinical trials is BMS-986393 in?

BMS-986393 is being studied in two clinical trials. NCT06121843 is a Phase 1 trial evaluating the drug in combinations for relapsed and/or refractory multiple myeloma. NCT06615479 is the Phase 3 QUINTESSENTIAL-2 trial comparing BMS-986393 to standard regimens in lenalidomide-exposed multiple myeloma.

Is BMS-986393 the same as Arlocabtagene Autoleucel?

Yes, BMS-986393 is also known as Arlocabtagene Autoleucel. The Phase 1 clinical trial NCT06121843 uses this alternative name in its title, confirming that both names refer to the same investigational drug.

Is BMS-986393 FDA approved?

BMS-986393 is not FDA approved. It is an investigational drug currently in clinical development, with active trials in Phase 1 and Phase 3 for multiple myeloma. Its safety and effectiveness have not yet been established for commercial use.