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idecabtagene vicleucel

Phase 3

Multiple Myeloma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 5, 2026

Target and mechanism

Molecular targetTNFRSF17
Target classBinding Agent
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

idecabtagene vicleucel · 1 trial · 1 indication

Phase 3 1
NCT06045806A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell TransplantationMultiple Myeloma
ACTIVE NOT_RECRUITING79 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
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Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Up to approximately 50 months after the first participant is randomized

PFS as assessed by Independent Review Committee (IRC)

Secondary Endpoints

Overall Survival (OS)
Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
From randomization up to 60 months from randomization
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
From randomization up to 15 months from randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
idecabtagene vicleucelBIOLOGICALSpecified dose on specified days
LenalidomideDRUGSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria * Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of...

Countries:United StatesAustraliaAustriaBelgiumCanadaDenmarkFranceGermanyGreeceIsraelItalyJapanNorwayPolandRomaniaSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Multiple Myeloma 221 trials

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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Frequently asked questions about idecabtagene vicleucel

What is idecabtagene vicleucel used for?

Idecabtagene vicleucel is an investigational cell therapy being studied for the treatment of multiple myeloma. It is currently in Phase 3 clinical development for adult patients with newly diagnosed multiple myeloma who have a suboptimal response after autologous stem cell transplantation.

Who is developing idecabtagene vicleucel?

Idecabtagene vicleucel is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting a Phase 3 clinical trial to evaluate the therapy in patients with multiple myeloma.

What phase is idecabtagene vicleucel in?

Idecabtagene vicleucel is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants.

What clinical trials is idecabtagene vicleucel in?

Idecabtagene vicleucel is being studied in a Phase 3 clinical trial with the identifier NCT06045806. This randomized, active-controlled trial compares idecabtagene vicleucel plus lenalidomide maintenance therapy versus lenalidomide maintenance therapy alone in adults with newly diagnosed multiple myeloma who have a suboptimal response after autologous stem cell transplantation.

How does idecabtagene vicleucel work?

Idecabtagene vicleucel is a cell therapy, classified as a -cel (cell therapy) modality. It is being investigated for its potential to treat multiple myeloma by targeting and eliminating cancer cells, though the specific molecular target is not disclosed in available information.