ClinicalTrials.gov record NCT06158854
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
An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This open-label Phase 1/2 study gives adults with AL amyloidosis repeated intravenous infusions of Etentamig (ABBV-383). The study has two parts: a dose-escalation phase to find appropriate doses and a dose-expansion phase using the selected dose. It will track adverse events and measures of disease activity over about a two-year treatment period.
What it is studying. The study is testing the safety (including dose-limiting toxicities and adverse events) and the effect of ABBV-383 on hematologic and organ measures of AL amyloidosis when given by IV infusion.
What the researchers hope to learn. To identify dose-limiting toxicities and adverse events of ABBV-383; to measure hematologic complete response rate, overall hematologic response, time to and duration of response; and to assess organ response rates and timing, per modified International Amyloidosis Consensus Criteria.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- ABBV-383 (Etentamig)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Have at least 1 organ historically impacted by AL amyloidosis.
- Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy.
- Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Exclusion criteria
- Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class.
- Participant has the following conditions:
- Other non-AL amyloid disease;
- Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium > 11 mg/dL);
- Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential);
- Waldenström's macroglobulinemia;
- Acute diffuse infiltrative pneumopathy;
- Major surgery within 28 days prior first dose or planned during study participation;
- History of organ transplant requiring continued use of immunosuppressants;
- Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
- Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive ABBV‑383 (etentamig) as an intravenous (IV) infusion and may be entered into dose‑escalation (one of three doses) or a dose‑expansion arm using the selected dose. Treatment and follow‑up occur over roughly a 2‑year study period (outcomes are assessed up to 4 years). Expect regular clinic or hospital visits for medical assessments, blood tests, monitoring for side effects, and questionnaires. The study notes a potentially higher treatment burden than standard care.
How the study is structured. Interventional, open-label Phase 1/2 trial with no masking. Participants are assigned to one of four arms in a sequential design: three dose-escalation arms to identify a dose, followed by a dose-expansion arm using the selected dose. Treatment is given by intravenous infusion and participants are followed for safety and disease response for up to about two years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Australia, France, Greece, Italy, Japan, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Apr 1, 2024
- Primary completion
- February 2028 (estimated)
- Study completion
- August 2031 (estimated)
- Target enrollment
- 76 participants (estimated)
- Last updated on registry
- May 13, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- AbbVie
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- ABBVIE CALL CENTER 📞 844-663-3742 ✉ abbvieclinicaltrials@abbvie.com
Participating sites (23)
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856Recruiting
Miami, Florida, 33136 · United States
- Boston Medical Center /ID# 255066Recruiting
Boston, Massachusetts, 02118 · United States
- Mayo Clinic - Rochester /ID# 255258Recruiting
Rochester, Minnesota, 55905-0001 · United States
- Icahn School of Medicine at Mount Sinai /ID# 255408Recruiting
New York, New York, 10029 · United States
- Columbia University Medical Center /ID# 255068Recruiting
New York, New York, 10032-3729 · United States
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073Recruiting
New York, New York, 10065-6007 · United States
- Atrium Health Levine Cancer Institute /ID# 255074Recruiting
Charlotte, North Carolina, 28204 · United States
- Atrium Health Wake Forest Baptist Medical Center /ID# 255851Recruiting
Winston-Salem, North Carolina, 27157 · United States
- Oregon Medical Research Center /ID# 255119Recruiting
Portland, Oregon, 97239 · United States
- Vanderbilt University Medical Center. /ID# 273510Recruiting
Nashville, Tennessee, 37232 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- investigational drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- dose escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- relapsed/refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- difference between involved and uninvolved free light chains
- The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
- line of therapy
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- immunosuppressants
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- autologous stem cell transplant
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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