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Etentamig

Phase 3

Amyloid Light Chain (AL) Amyloidosis | Small molecule | Other |AbbVie Inc.|Trials Updated: Oct 19, 2026

Etentamig development status

Highest phase Phase 3
Registered trials 10 across 2 sponsors since Mar 2022

Etentamig target and mechanism

ModalitySmall molecule

Also known as Subcutaneous (SC) Etentamig, Etentamig (ABBV-383), ABBV-383

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials11
Total Enrollment3,365

FDA Designations

No designations recorded

Etentamig clinical trials

Etentamig · 11 trials · 5 indications

Phase 3 3Phase 2 1Phase 1 7
NCT07728188A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple Myeloma
NOT YET_RECRUITING520 Analytics
NCT07793422Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) AmyloidosisAmyloid Light Chain (AL) Amyloidosis
NOT YET_RECRUITING370 Analytics
NCT06158841Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
ACTIVE NOT_RECRUITING421 Analytics
PHASE3NOT YET_RECRUITING
A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple MyelomaUnlock trial analytics
PHASE3NOT YET_RECRUITING
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Amyloid Light Chain (AL) AmyloidosisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Run-In: Number of Participants With Adverse Events (AE)s
Up to Approximately 75 Months

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

Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
Up to Approximately 75 Months

CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria. CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates. The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).

Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
Up to Approximately 75 Months

PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.

Number of Participants With Adverse Events
Up to Approximately 96 Months

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety and tolerability assessed through adverse events, laboratory tests, vital signs, physical examinations, and other safety assessments.

Randomized Portion: Complete Hematologic Response (HemeCR) Rate
Up to Approximately 60 Months

HemeCR rate is defined as the proportion of subjects with the best overall response of hemeCR as determined by International Amyloidosis Consensus Criteria (IACC) and assessed by the independent review committee (IRC)

Randomized Portion: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Up to Approximately 60 Months

MOD-PFS is defined as the time from the date of randomization to the date of MOD-PFS event or death from any cause, whichever occurs first. MOD-PFS includes: Development of hematologic progressive disease per consensus guidelines or high-risk difference in free light chain (dFLC) progression; Clinical manifestation of cardiac failure (defined as need for cardiac transplant, left ventricular assist device, or intra-aortic balloon pump); Clinical manifestation of renal failure (defined as development of end-stage renal disease needing hemodialysis or renal transplant); Death. MOD-PFS will be assessed by an Independent Review Committee.

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.

Substudy 5: DLT of ABBV-2001 in Combination with Iberdomide in Participants with 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 6: DLT of ABBV-2001 in Combination with Mezigdomide in Participants with 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 7: DLT of ABBV-2001 in Combination with Pomalidomide in Participants with 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 8: DLT of ABBV-2001 in Combination with Lenalidomide in Participants with 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.

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.

Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)
Up to 28 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.

Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)
Up to 4 years

Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).

Dose Expansion Only: Number of Participants with DLTs
Up to 4 years

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 (AEs)
Up to 4 years

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

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.

Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
Up to approximately 28 Days

DLT events as described in the protocol will be assessed.

Number of Dose-Limiting Toxicities (DLT)
Up to Approximately 12 Months

DLT events are defined as adverse events or abnormal laboratory values assessed as "reasonable possibility" of relationship to the administration of Etentamig, which cannot be attributed by the investigator to a clearly identifiable cause such as disease progression or concurrent illness.

Number of Participants with Adverse Events (AE)
Up to Approximately 24 Months

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.

Secondary Endpoints

Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
Up to Approximately 75 Months
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Up to Approximately 12 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Safety Run-In: Etentamig Plus PomalidomideEXPERIMENTALParticipants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Randomized Portion: Etentamig Plus PomalidomideEXPERIMENTALParticipants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Randomized Portion: Standard Available Therapy (SAT)ACTIVE_COMPARATORParticipants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
Safety Run-in: EtentamigEXPERIMENTALParticipants receive etentamig, as part of a 96 month study duration.
Randomized Portion: EtentamigEXPERIMENTALParticipants will receive etentamig , as part of a 96 month study duration.
Daratumumab + Cyclophosphamide + Bortezomib + DexamethasoneACTIVE_COMPARATORParticipants will receive daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in accordance with the local approved label, as part of a 96 month study duration..
EtentamigEXPERIMENTALParticipants will receive etentamig as a monotherapy.
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).
Phase 2 Cohort 1: 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 Cohort 1: 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 Cohort 1: 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 2 Cohort 2: Etentamig + Daratumumab Dose AEXPERIMENTALParticipants will receive subcutaneous (SC) etentamig dose A in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Phase 2 Cohort 2: Etentamig + Daratumumab Dose BEXPERIMENTALParticipants will receive subcutaneous (SC) etentamig dose B 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 ExpansionEXPERIMENTALParticipants will receive a recommended dose of etentamig in combination with DR, 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 ExpansionEXPERIMENTALParticipants will receive a recommended dose of etentamig, 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 ExpansionEXPERIMENTALParticipants will receive a recommended dose of etentamig in combination with carfilzomib (k), 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 ExpansionEXPERIMENTALParticipants will receive a recommended dose of etentamig in combination with R, as part of the approximately 130 month study duration.
Substudy 5: ABBV-2001 Dose EscalationEXPERIMENTALParticipants will receive up to two doses of ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.
Substudy 5: ABBV-2001 + Iberdomide at Combo Dose Level 1EXPERIMENTALParticipants will receive ABBV-2001 in combination with iberdomide at the combo dose level 1, as part of the approximately 130 month study duration.
Substudy 5: ABBV-2001 + Iberdomide at Combo Dose Level 2EXPERIMENTALParticipants will receive ABBV-2001 in combination with iberdomide, at the combo dose level 2, as part of the approximately 130-month study duration.
Substudy 6: ABBV-2001 Dose EscalationEXPERIMENTALParticipants will receive up to two doses of ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.
Substudy 6: ABBV-2001 + Mezigdomide at Combo Dose Level 1EXPERIMENTALParticipants will receive ABBV-2001 in combination with mezigdomide, at the combo dose level 1, as part of the approximately 130-month study duration.
Substudy 6: ABBV-2001 + Mezigdomide at Combo Dose Level 2EXPERIMENTALParticipants will receive ABBV-2001 in combination with mezigdomide, at the combo dose level 2, as part of the approximately 130-month study duration.
Substudy 7: ABBV-2001 Dose EscalationEXPERIMENTALParticipants will receive up to two doses of ABBV-2001 in combination with pomalidomide, as part of the approximately 130 month study duration.
Substudy 7: ABBV-2001 + Pomalidomide at Combo Dose Level 1EXPERIMENTALParticipants will receive ABBV-2001 in combination with pomalidomide, at the combo dose level 1, as part of the approximately 130-month study duration.
Substudy 7: ABBV-2001 + Pomalidomide at Combo Dose Level 2EXPERIMENTALParticipants will receive ABBV-2001 in combination with pomalidomide, at the combo dose level 2, as part of the approximately 130-month study duration.
Substudy 8: ABBV-2001 Dose EscalationEXPERIMENTALParticipants will receive up to two doses of ABBV-2001 in combination with lenalidomide, as part of the approximately 130 month study duration.
Substudy 8: ABBV-2001 + Lenalidomide at Combo Dose Level 1EXPERIMENTALParticipants will receive ABBV-2001 in combination with lenalidomide, at the combo dose level 1, as part of the approximately 130-month study duration.
Substudy 8: ABBV-2001 + Lenalidomide at Combo Dose Level 2EXPERIMENTALParticipants will receive ABBV-2001 in combination with lenalidomide, at the combo dose level 2, 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.
Dose Escalation: ABBV-383 (etentamig) Dose AEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.
Dose Escalation: ABBV-383 (etentamig) Dose BEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.
Dose Escalation: ABBV-383 (etentamig) Dose CEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.
Dose Expansion: ABBV-383 (etentamig)EXPERIMENTALParticipants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year 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.
Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)EXPERIMENTALParticipants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)EXPERIMENTALParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)EXPERIMENTALParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)EXPERIMENTALParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
Cohort 1 (Etentamig Dose A)EXPERIMENTALParticipants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive Etentamig Dose A in 21-day cycles.
Cohort 2 (Etentamig Dose B)EXPERIMENTALParticipants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles.

Interventions

NameTypeDescription
EtentamigDRUGInjection
PomalidomideDRUGOral
DaratumumabDRUGInjection
DexamethasoneDRUGOral or Injection
CarfilzomibDRUGInjection
TeclistamabDRUGInjection
CyclophosphamideDRUGOral
BortezomibDRUGInjection
ElotuzumabDRUGIV Infusion
SelinexorDRUGOral Tablet
LenalidomideDRUGOral Capsule
IberdomideDRUGOral Capsule
MezigdomideDRUGOral
ABBV-2001DRUGSubcutaneous (SC) Injection
Subcutaneous (SC) EtentamigDRUGSC Injection
Intravenous (IV) EtentamigDRUGIV Infusion
ABBV-383 (Etentamig)DRUGIntravenous Infusion
Etentamig (ABBV-383)DRUGIntravenous Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Diagnosis of relapsed or refractory (RR) multiple myeloma (MM). * Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide. * Adequate organ function and performance status Exclusion Criteria: * Prior B-cell maturation antigen (...

Countries:United StatesAustraliaCanadaFranceGermanyHungaryItalyNetherlandsNorwayPortugalSpainTaiwanUnited KingdomAustriaBelgiumChinaCzechiaDenmarkGreeceIsraelJapanPolandPuerto RicoSouth AfricaSouth KoreaSwedenTurkey (Türkiye)
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Recent Changes (Last 90 Days)

MEDIUMOct 19, 2026NCT06892522Completion: 2035-12 → 2036-03
MEDIUMOct 19, 2026NCT07095452primaryCompletionDate: changed
MEDIUMOct 19, 2026NCT06892522Completion: 2035-12 → 2036-03
MEDIUMOct 19, 2026NCT07095452primaryCompletionDate: changed
MEDIUMOct 19, 2026NCT06892522Completion: 2035-12 → 2036-03
MEDIUMOct 19, 2026NCT07095452primaryCompletionDate: changed
MEDIUMSep 22, 2026NCT07095452Enrollment: 660 → 680
MEDIUMSep 22, 2026NCT07095452Enrollment: 660 → 680
LOWAug 28, 2026NCT07793422NEW_TRIAL: changed
LOWAug 28, 2026NCT07793422NEW_TRIAL: changed
MEDIUMAug 27, 2026NCT06158841Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 27, 2026NCT06158841Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 14, 2026NCT05259839lastUpdatePostDate: changed
LOWAug 14, 2026NCT05259839lastUpdatePostDate: changed
LOWAug 3, 2026NCT06158841lastUpdatePostDate: changed
LOWAug 3, 2026NCT06158841lastUpdatePostDate: changed
LOWJul 27, 2026NCT07728188NEW_TRIAL: changed
LOWJul 27, 2026NCT06158841lastUpdatePostDate: changed
LOWJul 27, 2026NCT07728188NEW_TRIAL: changed
LOWJul 27, 2026NCT06158841lastUpdatePostDate: changed

Frequently asked questions about Etentamig

What is Etentamig used for?

Etentamig is an investigational therapy being studied for Amyloid Light Chain (AL) Amyloidosis and for Multiple Myeloma, including newly diagnosed, relapsed, and relapsed or refractory disease. It is being evaluated both as a single agent in combination regimens and against active comparators in Phase 3 and Phase 2 clinical trials.

Who is developing Etentamig?

Etentamig is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is running the clinical development program, which includes six active trials spanning Phase 1 through Phase 3 across AL Amyloidosis and Multiple Myeloma.

What phase is Etentamig in?

Etentamig is in Phase 3 development. Six trials are active and none are completed, with a combined planned enrollment of 2,108 participants. The program includes Phase 3 studies in AL Amyloidosis and relapsed or refractory Multiple Myeloma, a Phase 2 study in newly diagnosed Multiple Myeloma, and a Phase 1 study.

What clinical trials is Etentamig in?

Etentamig is being studied in NCT07793422, a Phase 3 trial in AL Amyloidosis comparing subcutaneous Etentamig with Dara-CyBorD; NCT07728188, a Phase 3 trial in relapsed or refractory Multiple Myeloma; NCT07095452, a Phase 2 trial in newly diagnosed Multiple Myeloma; and NCT06896916, a Phase 1 trial in relapsed or refractory Multiple Myeloma.

Is Etentamig the same as ABBV-383?

Yes. Etentamig is also known as ABBV-383, and the subcutaneous form is referred to as Subcutaneous (SC) Etentamig. These names refer to the same investigational agent being developed by AbbVie, so searches for ABBV-383 and Etentamig point to the same clinical program.

Is Etentamig FDA approved?

Etentamig is not approved and remains an investigational agent in clinical development. It is currently being evaluated in Phase 3, Phase 2, and Phase 1 trials, including active-controlled studies, and no completed trials have been reported for the program.