Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Subcutaneous (SC) Etentamig, Etentamig (ABBV-383), ABBV-383
Etentamig · 11 trials · 5 indications
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.
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).
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.
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.
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)
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Cmax of ABBV-383.
Tmax of ABBV-383.
Ctrough of ABBV-383.
AUC of ABBV-383.
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.
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).
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.
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.
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
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.
DLT events as described in the protocol will be assessed.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Safety Run-In: Etentamig Plus Pomalidomide | EXPERIMENTAL | Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration. |
| Randomized Portion: Etentamig Plus Pomalidomide | EXPERIMENTAL | Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration. |
| Randomized Portion: Standard Available Therapy (SAT) | ACTIVE_COMPARATOR | Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration. |
| Safety Run-in: Etentamig | EXPERIMENTAL | Participants receive etentamig, as part of a 96 month study duration. |
| Randomized Portion: Etentamig | EXPERIMENTAL | Participants will receive etentamig , as part of a 96 month study duration. |
| Daratumumab + Cyclophosphamide + Bortezomib + Dexamethasone | ACTIVE_COMPARATOR | Participants 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.. |
| Etentamig | EXPERIMENTAL | Participants will receive etentamig as a monotherapy. |
| Standard Available Therapy (SAT) | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants 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 B | EXPERIMENTAL | Participants 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 C | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants 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 B | EXPERIMENTAL | Participants 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 RP3D | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants will receive DRd, as part of the approximately 16 year study duration. |
| Phase 1: ABBV-383 Dose Escalation | EXPERIMENTAL | In 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 A | EXPERIMENTAL | In 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 B | EXPERIMENTAL | In 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 Escalation | EXPERIMENTAL | Participants 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 | EXPERIMENTAL | Participants will receive a recommended dose of etentamig in combination with DR, as part of the approximately 130 month study duration. |
| Substudy 2: Etentamig Dose Escalation | EXPERIMENTAL | Participants will receive escalating etentamig, as part of the approximately 130 month study duration. |
| Substudy 2: Etentamig Dose Expansion | EXPERIMENTAL | Participants will receive a recommended dose of etentamig, as part of the approximately 130 month study duration. |
| Substudy 3: Etentamig Dose Escalation | EXPERIMENTAL | Participants 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 | EXPERIMENTAL | Participants 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 Escalation | EXPERIMENTAL | Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration. |
| Substudy 4: Etentamig Dose Expansion | EXPERIMENTAL | Participants 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 Escalation | EXPERIMENTAL | Participants 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 Escalation | EXPERIMENTAL | Participants 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 Escalation | EXPERIMENTAL | Participants 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 Escalation | EXPERIMENTAL | Participants 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration. |
| Etentamig Dose B | EXPERIMENTAL | Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration. |
| Etentamig Expansion | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration. |
| Dose Escalation: ABBV-383 (etentamig) Dose B | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration. |
| Dose Escalation: ABBV-383 (etentamig) Dose C | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration. |
| Dose Expansion: ABBV-383 (etentamig) | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration. |
| Arm A (Part 1): ABBV-383 Dose Escalation | EXPERIMENTAL | B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles. |
| Arm A (Part 2): ABBV-383 Dose Expansion | EXPERIMENTAL | BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles. |
| Arm B: ABBV-383 BCMA Exposed | EXPERIMENTAL | Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles. |
| Arm C: ABBV-383 Step Up | EXPERIMENTAL | Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles. |
| Arm D: ABBV-383 Step Up | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| Etentamig | DRUG | Injection |
| Pomalidomide | DRUG | Oral |
| Daratumumab | DRUG | Injection |
| Dexamethasone | DRUG | Oral or Injection |
| Carfilzomib | DRUG | Injection |
| Teclistamab | DRUG | Injection |
| Cyclophosphamide | DRUG | Oral |
| Bortezomib | DRUG | Injection |
| Elotuzumab | DRUG | IV Infusion |
| Selinexor | DRUG | Oral Tablet |
| Lenalidomide | DRUG | Oral Capsule |
| Iberdomide | DRUG | Oral Capsule |
| Mezigdomide | DRUG | Oral |
| ABBV-2001 | DRUG | Subcutaneous (SC) Injection |
| Subcutaneous (SC) Etentamig | DRUG | SC Injection |
| Intravenous (IV) Etentamig | DRUG | IV Infusion |
| ABBV-383 (Etentamig) | DRUG | Intravenous Infusion |
| Etentamig (ABBV-383) | DRUG | Intravenous Infusion |
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 (...
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.
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.
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.
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.
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.
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.