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

NCT05650632
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
210
clinicaltrials.gov
Lead sponsor
AbbVie
clinicaltrials.gov
Start date
2023-03-21
clinicaltrials.gov
Number of sites
46
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Short title
A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma
clinicaltrials.gov
Official title
A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-08-01
clinicaltrials.gov
First posted
2022-12-14
clinicaltrials.gov
Registry last updated
2026-07-13
clinicaltrials.gov
Primary completion date
2029-08-01
clinicaltrials.gov
Start date
2023-03-21
clinicaltrials.gov

Participants
210
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
210
clinicaltrials.gov
Protocol amendments
4
clinicaltrials.gov
Number of sites
46
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
AbbVie
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05650632
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05650632
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events

    Timeframe: Up to Day 28

    CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

  2. Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])

    Timeframe: Up to Day 28

    AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  1. Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events

    Timeframe: Up to 3 Years

    CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Must have measurable disease as outlined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C and Arm D: ECOG performance of <= 1.
  • Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
  • Must be naïve to treatment with etentamig (ABBV-383).
  • Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
  • Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).
  • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
  • Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

  • Arm A: Received BCMA-targeted therapy.
  • Arm C and Arm D: Rapidly progressing disease per investigator.
Sources for eligibility
clinicaltrials.gov

  • Mayo Clinic Arizona /ID# 251405Phoenix, United StatesRecruiting
  • Highlands Oncology Group - Springdale /ID# 267742Springdale, United StatesRecruiting
  • Rocky Mountain Cancer Centers - Aurora /ID# 268574Aurora, United StatesRecruiting
  • Medical Oncology Hematology Consultants /ID# 268560Newark, United StatesRecruiting
  • Hope And Healing Cancer Services /ID# 268536Hinsdale, United StatesRecruiting
  • Fort Wayne Medical Oncology And Hematology /ID# 268179Fort Wayne, United StatesRecruiting
  • Franciscan St. Francis Health /ID# 280928Indianapolis, United StatesRecruiting
  • Tulane University School of Medicine /ID# 251204New Orleans, United StatesRecruiting
  • Maryland Oncology Hematology - Silver Spring /ID# 268562Silver Spring, United StatesNot yet recruiting
  • Mayo Clinic - Rochester /ID# 251164Rochester, United StatesRecruiting
  • NHO Revive Research Institute, LLC /ID# 267869Lincoln, United StatesRecruiting
  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497Omaha, United StatesRecruiting
  • Mt Sinai /ID# 251166New York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167New York, United StatesRecruiting
  • University of North Carolina /ID# 251203Chapel Hill, United StatesRecruiting
  • Atrium Health Wake Forest Baptist Medical Center /ID# 251165Winston-Salem, United StatesRecruiting
  • University Of Cincinnati Medical Center /ID# 251746Cincinnati, United StatesRecruiting
  • Willamette Valley Cancer Institute and Research Center /ID# 267088Eugene, United StatesRecruiting
  • Baptist Memorial Hospital /ID# 280677Memphis, United StatesNot yet recruiting
  • Vanderbilt Ingram Cancer Center /ID# 252470Nashville, United StatesRecruiting
  • Texas Oncology - Central/South Texas /ID# 268563Austin, United StatesRecruiting
  • Texas Oncology - Dallas - Worth Street /ID# 280064Dallas, United StatesRecruiting
  • Oncology Consultants /ID# 268323Houston, United StatesRecruiting
  • Texas Oncology - Northeast Texas /ID# 268877Tyler, United StatesRecruiting
  • Virginia Cancer Specialists - Fairfax /ID# 268559Fairfax, United StatesRecruiting

And 21 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-504674-38-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)