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A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion
NCT06158854 · View on ClinicalTrials.gov ↗
Study Summary
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world. Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration. 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 ABBV-383 (Etentamig)
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai /ID# 255408 — New York
- Columbia University Medical Center /ID# 255068 — New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073 — New York
North Carolina
- Atrium Health Levine Cancer Institute /ID# 255074 — Charlotte
- Atrium Health Wake Forest Baptist Medical Center /ID# 255851 — Winston-Salem
Florida
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856 — Miami
Massachusetts
- Boston Medical Center /ID# 255066 — Boston
Minnesota
- Mayo Clinic - Rochester /ID# 255258 — Rochester
Oregon
- Oregon Medical Research Center /ID# 255119 — Portland
Washington
- University of Washington /ID# 261581 — Seattle
Wisconsin
- Wisconsin Medical Center /ID# 255836 — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2031-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06158854
The ClinicalTrials.gov registry entry for NCT06158854 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Immunoglobulin Light Chain (AL) Amyloidosis appearing as the primary indexed condition, and to 1 intervention — of which ABBV-383 (Etentamig) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06158854 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06158854 about?
NCT06158854 is a clinical study titled "A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion". Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease ac...
What is the current status of trial NCT06158854?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2024-04-01. Estimated completion is 2031-09.
What conditions does trial NCT06158854 study?
This clinical trial studies the following conditions: Immunoglobulin Light Chain (AL) Amyloidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06158854?
The interventions under investigation include: ABBV-383 (Etentamig) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06158854?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06158854 being conducted?
This trial has 20 study locations across Florida, Massachusetts, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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