A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT05650632
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world. Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 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
Mar 21, 2023
Status verified
Jun 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Part 1): ABBV-383 Dose Escalation
    B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
  • Experimental: Arm A (Part 2): ABBV-383 Dose Expansion
    BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
  • Experimental: Arm B: ABBV-383 BCMA Exposed
    Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
  • Experimental: Arm C: ABBV-383 Step Up
    Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
  • Experimental: Arm D: ABBV-383 Step Up
    Participants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Primary Outcome Measure

Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to Day 28 ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Mayo Clinic Arizona /ID# 251405PhoenixArizona85054-
Highlands Oncology Group - Springdale /ID# 267742SpringdaleArkansas72762-
Rocky Mountain Cancer Centers - Aurora /ID# 268574AuroraColorado80012-
Medical Oncology Hematology Consultants /ID# 268560NewarkDelaware19713-
Hope And Healing Cancer Services /ID# 268536HinsdaleIllinois60521-
Fort Wayne Medical Oncology And Hematology /ID# 268179Fort WayneIndiana46804-
Tulane University School of Medicine /ID# 251204New OrleansLouisiana70112-
Maryland Oncology Hematology - Silver Spring /ID# 268562Silver SpringMaryland20904-
Mayo Clinic - Rochester /ID# 251164RochesterMinnesota55905-0001-
NHO Revive Research Institute, LLC /ID# 267869LincolnNebraska68506-
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497OmahaNebraska68130-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167New YorkNew York10065-6007-
Mt Sinai /ID# 251166New YorkNew York10029-6542-
University of North Carolina /ID# 251203Chapel HillNorth Carolina27514-
Atrium Health Wake Forest Baptist Medical Center /ID# 251165Winston-SalemNorth Carolina27157-
University Of Cincinnati Medical Center /ID# 251746CincinnatiOhio45219-
Willamette Valley Cancer Institute and Research Center /ID# 267088EugeneOregon97401-
Baptist Memorial Hospital /ID# 280677MemphisTennessee38120-
Vanderbilt Ingram Cancer Center /ID# 252470NashvilleTennessee37232-0021-
Texas Oncology - Central/South Texas /ID# 268563AustinTexas78705-
Texas Oncology - Dallas - Worth Street /ID# 280064DallasTexas75246-
Oncology Consultants /ID# 268323HoustonTexas77030-
Texas Oncology - Northeast Texas /ID# 268877TylerTexas75702-
Virginia Cancer Specialists - Fairfax /ID# 268559FairfaxVirginia22031-
Fred Hutchinson Cancer Center. /ID# 267940SeattleWashington98109-4405-
Northwest Medical Specialties Tacoma /ID# 267117TacomaWashington98405-

Find similar trials in Phoenix, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Arizona· Phoenix, AZHighlands Oncology Group - Springdale· Springdale, ARRocky Mountain Cancer Centers - Aurora· Aurora, COMedical Oncology Hematology Consultants· Newark, DEHope And Healing Cancer Services· Hinsdale, ILFort Wayne Medical Oncology And Hematology· Fort Wayne, IN

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