Recruiting
Phase 1
Phase 2

Etentamig

Sponsor:

AbbVie

Code:

NCT06892522

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etentamig

Lenalidomide

Dexamethasone

Daratumumab

Dexamethasone

Study Details

Brief summary:

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig and ABBV-2001 in adult participants with MM.

Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 6 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd, R. Participants in substudies 1-4 can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Participants in substudies 5-6 will receive escalating doses or at the dose levels established during the escalation phases of ABBV-2001 with iberdomide or mezigdomide. Around 602 adult participants with MM will be enrolled at approximately 75 sites worldwide

In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or with IV and DRd, DKd, or R. In substudie 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by IV infusions of etentamig at the dose levels established during the escalation phase. In substudies 5-6, participants will receive escalating doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide or mezigdomide, followed by SC injections of ABBV-2001 at the dose levels established during the escalation phases with oral iberdomide or mezigdomide. The study duration is approximately 130 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Conditions

Multiple Myeloma

Study ID

NCT06892522

Start date

Jun 30, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eastern cooperative oncology group (ECOG) performance of <= 1.
  • Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.

Exclusion Criteria:

  • Participant who has known active central nervous system involvement of MM.
  • Participant who has known active infection as outlined in the protocol.

Study Design

Enrollment

602 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substudy 1: Etentamig Dose Escalation

Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.

experimental: Substudy 1: Etentamig Dose Expansion Dose Level 1

Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.

experimental: Substudy 1: Etentamig Dose Expansion Dose Level 2

Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.

experimental: Substudy 1: Comparator

Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.

experimental: Substudy 2: Etentamig Dose Escalation

Participants will receive escalating etentamig, as part of the approximately 130 month study duration.

experimental: Substudy 2: Etentamig Dose Expansion Dose Level 1

Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.

experimental: Substudy 2: Etentamig Dose Expansion Dose Level 2

Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.

experimental: Substudy 2: Comparator

Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.

experimental: Substudy 3: Etentamig Dose Escalation

Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.

experimental: Substudy 3: Etentamig Dose Expansion Dose Level 1

Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.

experimental: Substudy 3: Etentamig Dose Expansion Dose Level 2

Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.

experimental: Substudy 3: Comparator

Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.

experimental: Substudy 4: Etentamig Dose Escalation

Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.

experimental: Substudy 4: Etentamig Dose Expansion Dose Level 1

Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.

experimental: Substudy 4: Etentamig Dose Expansion Dose Level 2

Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.

experimental: Substudy 5: ABBV-2001 Dose Escalation

Participants will receive escalating ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.

experimental: Substudy 5: ABBV-2001 Dose Expansion Dose Level 1

Participants will receive dose level 1 of ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.

experimental: Substudy 5: ABBV-2001 Dose Expansion Dose Level 2

Participants will receive dose level 2 of ABBV-2001 in combination with iberdomide, as part of the approximately 130 month study duration.

experimental: Substudy 6: ABBV-2001 Dose Escalation

Participants will receive escalating ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.

experimental: Substudy 6: ABBV-2001 Dose Expansion Dose Level 1

Participants will receive dose level 1 of ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.

experimental: Substudy 6: ABBV-2001 Dose Expansion Dose Level 2

Participants will receive dose level 2 of ABBV-2001 in combination with mezigdomide, as part of the approximately 130 month study duration.

Interventions

Etentamig

Intravenous (IV) Infusion

Lenalidomide

Oral

Dexamethasone

IV Injection

Daratumumab

Subcutaneous Injection

Dexamethasone

Oral

Carfilzomib

IV Infusion

Mezigdomide

Oral

Iberdomide

Oral

ABBV-2001

subcutaneous (SC) Injection

Primary outcome measure

  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 130 Months ]
  • Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM) [ Time Frame: Up to Approximately 8 weeks ]
  • Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM) [ Time Frame: Up to Approximately 8 Weeks ]
  • Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM) [ Time Frame: Up to Approximately 8 Weeks ]
  • Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM [ Time Frame: Up to Approximately 8 Weeks ]
  • Substudy 5: DLT of ABBV-2001 in Combination with Iberdomide in Participants with RR MM [ Time Frame: Up to Approximately 8 Weeks ]
  • Substudy 6: DLT of ABBV-2001 in Combination with Mezigdomide in Participants with RR MM [ Time Frame: Up to Approximately 8 Weeks ]

Central Contacts and Locations

Central contacts

Locations

City of Hope National Medical Center /ID# 273132

Recruiting

Duarte, California, United States, 91010

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911

Recruiting

Irvine, California, United States, 92618

Colorado Blood Cancer Institute /ID# 273129

Recruiting

Denver, Colorado, United States, 80218

Moffitt Cancer Center /ID# 272628

Recruiting

Tampa, Florida, United States, 33612

Winship Cancer Institute of Emory University /ID# 274830

Recruiting

Atlanta, Georgia, United States, 30322

Mount Sinai - The Tisch Cancer Institute /ID# 272470

Recruiting

New York, New York, United States, 10029

Weill Cornell Medical College /ID# 272517

Recruiting

New York, New York, United States, 10065

University of North Carolina at Chapel Hill /ID# 274667

Recruiting

Chapel Hill, North Carolina, United States, 27514

Atrium Health Levine Cancer Institute /ID# 276193

Recruiting

Charlotte, North Carolina, United States, 28204-2990

Atrium Health Wake Forest Baptist Medical Center /ID# 274847

Recruiting

Winston-Salem, North Carolina, United States, 27157

Oncology Hematology Care - Blue Ash /ID# 272918

Recruiting

Cincinnati, Ohio, United States, 45252

The Ohio State University /ID# 271336

Recruiting

Columbus, Ohio, United States, 43210

University of Texas - Southwestern Medical Center /ID# 274360

Recruiting

Dallas, Texas, United States, 75235

Huntsman Cancer Institute /ID# 272575

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

AbbVie

Last update posted

Jul 21, 2026

Last verified

Jun, 2026

Keywords

  • Multiple Myeloma, Etentamig, ABBV-383, Cancer
  • Daratumumab
  • Lenalidomide
  • Dexamethasone
  • Carfilzomib
  • ABBV-2001
  • Iberdomide
  • Mezigdomide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-21.