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Etentamig

Phase 3

Multiple Myeloma | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jun 5, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials6
Total Enrollment1,885
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06158841Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple MyelomaPHASE3 RECRUITING 380May 19, 2024Dec 1, 2027Jun 5, 2026166 United States, Australia +23
NCT07095452A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for TransplantPHASE2 RECRUITING 660Jan 8, 2026Jan 1, 2042Jun 2, 202647 United States, France +2
NCT06896916Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple MyelomaPHASE1 RECRUITING 135Aug 7, 2025Mar 1, 2036May 12, 202627 United States, Australia +5
NCT06892522A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; CarfilzomibPHASE1 RECRUITING 440Jun 30, 2025Mar 1, 2036Feb 17, 202625 United States, Australia +3
NCT06223516Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple MyelomaPHASE1 ACTIVE NOT_RECRUITING 60Jun 17, 2024Dec 1, 2027Mar 27, 202615 United States, Germany +2
NCT05650632A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple MyelomaPHASE1 RECRUITING 210Mar 21, 2023Aug 1, 2029Jun 5, 202645 United States, Canada +5
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
Up to Approximately 5 Years

PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.

Objective Response Rate (ORR)
Up to Approximately 5 Years

ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.

Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s
Up to Approximately 16 Years

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Phase 2: Change in Clinical Activity
Up to Approximately 52 weeks

Clinical activity is defined as change in response rates \[Overall Response Rate (ORR), Complete Response (CR) or Better, Very Good Partial Response (VGPR), Partial Response (PR)\] as determined International Myeloma Working Group (IMWG (2016).

Phase 3: Minimal Residual Disease (MRD) Negative CR Rate
Up to Approximately 52 weeks

MRDnegCR rate, is defined as the percentage of participants who have achieved stringent complete response (sCR) or CR as assessed by independent review committee (IRC) and have negative MRD defined at 10\^-5 threshold as assessed by next generation sequencing (NGS).

Phase 3: Progression-Free Survival (PFS)
Up to Approximately 130 Months

PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.

Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
Up to Approximately 56 Days

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Number of Participants with Adverse Events (AE)s
Up to Approximately 129 Months

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
Up to Approximately 8 weeks

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)
Up to Approximately 8 Weeks

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)
Up to Approximately 8 Weeks

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM
Up to Approximately 8 Weeks

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
Up to 2 cycles (56 days)

Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.

Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Up to 2 cycles (56 days)

ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.

Maximum Observed Concentration (Cmax) of ABBV-383
Up to 32 weeks

Cmax of ABBV-383.

Time to Cmax (Tmax) of ABBV-383
Up to 32 weeks

Tmax of ABBV-383.

Trough Concentration (Ctrough) of ABBV-383
Up to 32 weeks

Ctrough of ABBV-383.

Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
Up to 24 weeks

AUC of ABBV-383.

Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
Up to Day 28

CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
Up to Day 28

AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Secondary Endpoints
Overall Survival (OS)
Up to Approximately 5 Years
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
Up to Approximately 5 Years
Change in Rate of CR or Better (>=CR)
Up to Approximately 5 Years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Standard Available Therapy (SAT)EXPERIMENTALParticipants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
EtentamigEXPERIMENTALParticipants will receive etentamig as a monotherapy.
Phase 2: Etentamig + Daratumumab Dose AEXPERIMENTALParticipants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration.
Phase 2: Etentamig + Daratumumab Dose BEXPERIMENTALParticipants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Phase 2: Etentamig + Daratumumab Dose CEXPERIMENTALParticipants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Phase 3: Etentamig + Daratumumab RP3DEXPERIMENTALParticipants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.
Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd)EXPERIMENTALParticipants will receive DRd, as part of the approximately 16 year study duration.
Phase 1: ABBV-383 Dose EscalationEXPERIMENTALIn phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
Phase 2: ABBV-383 Dose Expansion Dose AEXPERIMENTALIn phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
Phase 2: ABBV-383 Dose Expansion Dose BEXPERIMENTALIn phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
Substudy 1: Etentamig Dose EscalationEXPERIMENTALParticipants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Substudy 1: Etentamig Dose Expansion Dose Level 1EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Substudy 1: Etentamig Dose Expansion Dose Level 2EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Substudy 1: ComparatorEXPERIMENTALParticipants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose EscalationEXPERIMENTALParticipants will receive escalating etentamig, as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose Expansion Dose Level 1EXPERIMENTALParticipants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose Expansion Dose Level 2EXPERIMENTALParticipants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Substudy 2: ComparatorEXPERIMENTALParticipants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose EscalationEXPERIMENTALParticipants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose Expansion Dose Level 1EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose Expansion Dose Level 2EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Substudy 3: ComparatorEXPERIMENTALParticipants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose EscalationEXPERIMENTALParticipants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose Expansion Dose Level 1EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose Expansion Dose Level 2EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Etentamig Dose AEXPERIMENTALParticipants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
Etentamig Dose BEXPERIMENTALParticipants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
Etentamig ExpansionEXPERIMENTALParticipants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.
Arm A (Part 1): ABBV-383 Dose EscalationEXPERIMENTALB-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
Arm A (Part 2): ABBV-383 Dose ExpansionEXPERIMENTALBCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
Arm B: ABBV-383 BCMA ExposedEXPERIMENTALParticipants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
Arm C: ABBV-383 Step UpEXPERIMENTALParticipants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
Arm D: ABBV-383 Step UpEXPERIMENTALParticipants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
Interventions
NameTypeDescription
EtentamigDRUGIntravenous (IV) Infusion
CarfilzomibDRUGIV Infusion
PomalidomideDRUGOral Capsule
ElotuzumabDRUGIV Infusion
SelinexorDRUGOral Tablet
BortezomibDRUGSubcutaneous or IV Injection
DexamethasoneDRUGOral Tablet or IV Infusion
LenalidomideDRUGOral Capsule
DaratumumabDRUGSubcutaneous Injection
IberdomideDRUGOral Capsule
Subcutaneous (SC) EtentamigDRUGSC Injection
Intravenous (IV) EtentamigDRUGIV Infusion
Etentamig (ABBV-383)DRUGIntravenous Infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites166

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol. * Must have measurable disease with at least 1 of the following assessed w...

Countries:United StatesAustraliaAustriaBelgiumCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIsraelItalyJapanPolandPortugalPuerto RicoSouth AfricaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United KingdomNetherlandsNorway
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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 5, 2026NCT05650632lastUpdatePostDate: changed
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