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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Etentamig — DRUG
  Intravenous (IV) Infusion
• Lenalidomide — DRUG
  Oral Capsule
• Daratumumab — DRUG
  Subcutaneous Injection
• Dexamethasone — DRUG
  Oral Tablet
• Dexamethasone — DRUG
  IV Injection

Study Details

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.

Key Dates

Start date

Jan 8, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2042

Completion

Jan 31, 2042

Study Design

Enrollment

660 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 16 Years ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (17)

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