| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06158841 | Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma | PHASE3 | RECRUITING | 380 | — | — | May 19, 2024 | Dec 1, 2027 | Jun 5, 2026 | 166 | United States, Australia +23 |
| NCT07095452 | A 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 Transplant | PHASE2 | RECRUITING | 660 | — | — | Jan 8, 2026 | Jan 1, 2042 | Jun 2, 2026 | 47 | United States, France +2 |
| NCT06896916 | Study 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 Myeloma | PHASE1 | RECRUITING | 135 | — | — | Aug 7, 2025 | Mar 1, 2036 | May 12, 2026 | 27 | United States, Australia +5 |
| NCT06892522 | A 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; Carfilzomib | PHASE1 | RECRUITING | 440 | — | — | Jun 30, 2025 | Mar 1, 2036 | Feb 17, 2026 | 25 | United States, Australia +3 |
| NCT06223516 | Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 60 | — | — | Jun 17, 2024 | Dec 1, 2027 | Mar 27, 2026 | 15 | United States, Germany +2 |
| NCT05650632 | A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma | PHASE1 | RECRUITING | 210 | — | — | Mar 21, 2023 | Aug 1, 2029 | Jun 5, 2026 | 45 | United States, Canada +5 |
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Etentamig | EXPERIMENTAL | Participants will receive etentamig as a monotherapy. |
| Phase 2: 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: 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: 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 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 Dose Level 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration. |
| Substudy 1: Comparator | EXPERIMENTAL | Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), 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 Dose Level 1 | EXPERIMENTAL | Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration. |
| Substudy 2: Etentamig Dose Expansion Dose Level 2 | EXPERIMENTAL | Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration. |
| Substudy 2: Comparator | EXPERIMENTAL | Participants will receive lenalidomide (R), 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 Dose Level 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration. |
| Substudy 3: Comparator | EXPERIMENTAL | Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), 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 Dose Level 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants will receive dose level 2 of etentamig in combination with R, 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Etentamig | DRUG | Intravenous (IV) Infusion |
| Carfilzomib | DRUG | IV Infusion |
| Pomalidomide | DRUG | Oral Capsule |
| Elotuzumab | DRUG | IV Infusion |
| Selinexor | DRUG | Oral Tablet |
| Bortezomib | DRUG | Subcutaneous or IV Injection |
| Dexamethasone | DRUG | Oral Tablet or IV Infusion |
| Lenalidomide | DRUG | Oral Capsule |
| Daratumumab | DRUG | Subcutaneous Injection |
| Iberdomide | DRUG | Oral Capsule |
| Subcutaneous (SC) Etentamig | DRUG | SC Injection |
| Intravenous (IV) Etentamig | DRUG | IV Infusion |
| Etentamig (ABBV-383) | DRUG | Intravenous Infusion |
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...