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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Etentamig
    Intravenous (IV) Infusion
  • Drug: Daratumumab
    Subcutaneous Injection
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.
  • Drug: Etentamig
    Intravenous (IV) Infusion
  • Drug: Daratumumab
    Subcutaneous Injection
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.
  • Drug: Etentamig
    Intravenous (IV) Infusion
  • Drug: Daratumumab
    Subcutaneous Injection
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.
  • Drug: Etentamig
    Intravenous (IV) Infusion
  • Drug: Daratumumab
    Subcutaneous Injection
Experimental
Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd) 		Participants will receive DRd, as part of the approximately 16 year study duration.
  • Drug: Lenalidomide
    Oral Capsule
  • Drug: Daratumumab
    Subcutaneous Injection
  • Drug: Dexamethasone
    Oral Tablet
  • Drug: Dexamethasone
    IV Injection

Recruiting Locations

Mayo Clinic Hospital Scottsdale /ID# 278349
Scottsdale, Arizona 85259

Colorado Blood Cancer Institute /ID# 279080
Denver, Colorado 80218

Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, Indiana 46804

Minnesota Oncology - Minneapolis Clinic /ID# 278720
Minneapolis, Minnesota 55404

Mayo Clinic Hospital Rochester /ID# 277886
Rochester, Minnesota 55905

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
New York, New York 10065

University of North Carolina at Chapel Hill /ID# 277708
Chapel Hill, North Carolina 27514

Willamette Valley Cancer Institute and Research Center /ID# 278721
Eugene, Oregon 97401

SCRI Oncology Partners /ID# 278353
Nashville, Tennessee 37203

Texas Oncology - The Woodlands /ID# 278726
The Woodlands, Texas 77380

Texas Oncology - Northeast Texas /ID# 278725
Tyler, Texas 75702

Virginia Cancer Specialists - Fairfax /ID# 278716
Fairfax, Virginia 22031

Blue Ridge Cancer Care - Roanoke /ID# 278722
Roanoke, Virginia 24014

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.