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

Part of paid clinical trials in Denver, Colorado.

Sponsor
AbbVie
Study ID
NCT06892522
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

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. 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 in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. 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.

Key Dates

Start date
Jun 30, 2025
Status verified
Feb 2026
Primary completion
Feb 29, 2036
Completion
Mar 31, 2036

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 130 Months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer Institute /ID# 273129DenverColorado80218-
Moffitt Cancer Center /ID# 272628TampaFlorida33612-
Winship Cancer Institute of Emory University /ID# 274830AtlantaGeorgia30322-
Weill Cornell Medical College /ID# 272517New YorkNew York10065-
University of North Carolina at Chapel Hill /ID# 274667Chapel HillNorth Carolina27514-
Atrium Health Levine Cancer Institute /ID# 276193CharlotteNorth Carolina28204-2990-
Atrium Health Wake Forest Baptist Medical Center /ID# 274847Winston-SalemNorth Carolina27157-
Oncology Hematology Care - Kenwood /ID# 272918CincinnatiOhio45236-

Find similar trials in Denver, CO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Institute· Denver, COMoffitt Cancer Center· Tampa, FLWinship Cancer Institute of Emory University· Atlanta, GAWeill Cornell Medical College· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCAtrium Health Levine Cancer Institute· Charlotte, NC

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