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
AbbVie · NCT06158854
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 76
- US sites recruiting
- 12
- Study start
- April 1, 2024
- Record last updated
- May 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ABBV-383 (Etentamig)
Conditions: Immunoglobulin Light Chain (AL) Amyloidosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, FL 33136
Boston Medical Center /ID# 255066
Boston, MA 02118
Mayo Clinic - Rochester /ID# 255258
Rochester, MN 55905-0001
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, NY 10029
Columbia University Medical Center /ID# 255068
New York, NY 10032-3729
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, NY 10065-6007
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, NC 28204
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, NC 27157
Oregon Medical Research Center /ID# 255119
Portland, OR 97239
Vanderbilt University Medical Center. /ID# 273510
Nashville, TN 37232
University of Washington /ID# 261581
Seattle, WA 98109
Wisconsin Medical Center /ID# 255836
Milwaukee, WI 53226
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Similar studies in Florida
All phase 1 studies in Florida →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study of LY4302814 in Healthy Participants
Eli Lilly and Company
- Location
- Daytona Beach, FL
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Pfizer
- Location
- Orlando, FL + 3 other US sites
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
BioCorRx Pharmaceuticals Inc
- Location
- Miami, FL
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Arcutis Biotherapeutics, Inc.
- Location
- Miami, FL + 6 other US sites
- Eligibility basics
- Ages 18–65