A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations

Part of paid clinical trials in Duarte, California.

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
  • Dexamethasone — DRUG
    IV Injection
  • Daratumumab — DRUG
    Subcutaneous Injection
  • Dexamethasone — DRUG
    Oral
  • Carfilzomib — DRUG
    IV Infusion
  • Mezigdomide — DRUG
    Oral
  • Iberdomide — DRUG
    Oral
  • ABBV-2001 — DRUG
    subcutaneous (SC) 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. 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.

Key Dates

First listed
Mar 24, 2025
Start date
Jun 30, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
602 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 273132DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911IrvineCalifornia92618-
Colorado Blood Cancer Institute /ID# 273129DenverColorado80218-
Moffitt Cancer Center /ID# 272628TampaFlorida33612-
Winship Cancer Institute of Emory University /ID# 274830AtlantaGeorgia30322-
Mount Sinai - The Tisch Cancer Institute /ID# 272470New YorkNew York10029-
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 - Blue Ash /ID# 272918CincinnatiOhio45252-
The Ohio State University /ID# 271336ColumbusOhio43210-
University of Texas - Southwestern Medical Center /ID# 274360DallasTexas75235-
Huntsman Cancer Institute /ID# 272575Salt Lake CityUtah84112-

Find similar trials in Duarte, CA

Nationwide
Multiple myeloma trialsOncology trialsBlood cancer trials
By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAColorado Blood Cancer Institute· Denver, COMoffitt Cancer Center· Tampa, FLWinship Cancer Institute of Emory University· Atlanta, GAMount Sinai - The Tisch Cancer Institute· New York, NY

Related Studies