Recruiting
Phase 2
Phase 3

Etentamig & Daratumumab

Sponsor:

AbbVie

Code:

NCT07095452

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etentamig

Lenalidomide

Daratumumab

Dexamethasone

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. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.

Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide

Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.

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

NCT07095452

Start date

Jan 8, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2042

Anticipated

Primary completion date

Jan, 2042

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
  • IMWG Myeloma Frailty Index Score of >= 1
  • All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:

  • Serum M-protein >= 0.5 g/dL (>= 5 g/L).
  • Urine M-protein >= 200 mg/24 hours.
  • Serum free light chain (FLC) >= 100 mg/L (>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.

Exclusion Criteria:

  • Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
  • Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
  • Participant who has known active central nervous system involvement of MM.
  • Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 2: Etentamig + Daratumumab Dose A

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.

experimental: Phase 2: Etentamig + Daratumumab Dose B

Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.

experimental: Phase 2: Etentamig + Daratumumab Dose C

Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.

experimental: Phase 3: Etentamig + Daratumumab RP3D

Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.

experimental: Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd)

Participants will receive DRd, as part of the approximately 16 year study duration.

Interventions

Etentamig

Intravenous (IV) Infusion

Lenalidomide

Oral Capsule

Daratumumab

Subcutaneous Injection

Dexamethasone

Oral Tablet

Dexamethasone

IV Injection

Primary outcome measure

  • Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 16 Years ]
  • Phase 2: Change in Clinical Activity [ Time Frame: Up to Approximately 52 weeks ]
  • Phase 3: Minimal Residual Disease (MRD) Negative CR Rate [ Time Frame: Up to Approximately 52 weeks ]
  • Phase 3: Progression-Free Survival (PFS) [ Time Frame: Up to Approximately 130 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Mayo Clinic Hospital Scottsdale /ID# 278349

Recruiting

Scottsdale, Arizona, United States, 85259

Cedars-Sinai Medical Center /ID# 278238

Recruiting

Los Angeles, California, United States, 90048

Colorado Blood Cancer Institute /ID# 279080

Recruiting

Denver, Colorado, United States, 80218

Winship Cancer Institute of Emory University /ID# 277667

Recruiting

Atlanta, Georgia, United States, 30322

Fort Wayne Medical Oncology And Hematology /ID# 278141

Recruiting

Fort Wayne, Indiana, United States, 46804

Minnesota Oncology - Minneapolis Clinic /ID# 278720

Recruiting

Minneapolis, Minnesota, United States, 55404

Mayo Clinic Hospital Rochester /ID# 277886

Recruiting

Rochester, Minnesota, United States, 55905

Icahn School of Medicine at Mount Sinai /ID# 277844

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946

Recruiting

New York, New York, United States, 10065

Weill Cornell Medicine Myeloma Center /ID# 278216

Recruiting

New York, New York, United States, 10065

University of North Carolina at Chapel Hill /ID# 277708

Recruiting

Chapel Hill, North Carolina, United States, 27514

Willamette Valley Cancer Institute and Research Center /ID# 278721

Recruiting

Eugene, Oregon, United States, 97401

SCRI Oncology Partners /ID# 278353

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - The Woodlands /ID# 278726

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Northeast Texas /ID# 278725

Recruiting

Tyler, Texas, United States, 75702

Virginia Cancer Specialists - Fairfax /ID# 278716

Recruiting

Fairfax, Virginia, United States, 22031

Blue Ridge Cancer Care - Roanoke /ID# 278722

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

AbbVie

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Multiple Myeloma
  • Etentamig
  • Daratumumab
  • Lenalidomide
  • Dexamethasone

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 2026-06-11.