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NCT05650632 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT05650632: Recruiting Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
NCT05650632 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 210 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05650632, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Etentamig (ABBV-383)
Study Locations (20)
Texas
- Texas Oncology - Central/South Texas /ID# 268563 - Austin
- Oncology Consultants /ID# 268323 - Houston
- Texas Oncology - Northeast Texas /ID# 268877 - Tyler
New York
- Mt Sinai /ID# 251166 - New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167 - New York
North Carolina
- University of North Carolina /ID# 251203 - Chapel Hill
- Atrium Health Wake Forest Baptist Medical Center /ID# 251165 - Winston-Salem
Arizona
- Mayo Clinic Arizona /ID# 251405 - Phoenix
Arkansas
- Highlands Oncology Group - Springdale /ID# 267742 - Springdale
Colorado
- Rocky Mountain Cancer Centers - Aurora /ID# 268574 - Aurora
Delaware
- Medical Oncology Hematology Consultants /ID# 268560 - Newark
Illinois
- Hope And Healing Cancer Services /ID# 268536 - Hinsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05650632
The ClinicalTrials.gov registry entry for NCT05650632 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (62% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Etentamig (ABBV-383) is the first listed.
NCT05650632 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Texas, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05650632 about?
NCT05650632 is a clinical study titled "A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma". 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 ...
What is the current status of trial NCT05650632?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2023-03-21. Estimated completion is 2029-08.
What conditions does trial NCT05650632 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05650632?
The interventions under investigation include: Etentamig (ABBV-383) (DRUG).
Who is sponsoring clinical trial NCT05650632?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05650632 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Colorado, Delaware, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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