Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-13
76
Participants Needed
23
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- At least one organ previously affected by AL amyloidosis.
- Classified as AL amyloidosis cardiac risk stage 1, 2, or 3a; or stage 3b with stable cardiac function and markers for 3 months before dosing.
- Measurable AL amyloidosis disease defined by difference between involved and uninvolved free light chains (dFLC) of 50 mg/L or more, or meeting high-risk dFLC progression criteria after immediate prior therapy.
- Previous exposure to a proteasome inhibitor and an anti-CD38 monoclonal antibody.
You will not qualify if you...
- History of clinically significant drug or alcohol abuse within the last 6 months.
- Known allergy, sensitivity, or intolerance to study treatment components or similar products.
- Presence of other non-AL amyloid diseases.
- Previous or current symptomatic multiple myeloma including lytic bone disease, plasmacytomas, 60% or more plasma cells in bone marrow, or high calcium levels (corrected calcium above 11 mg/dL).
- Active plasma cell leukemia.
- Waldenström's macroglobulinemia.
- Acute diffuse infiltrative pneumopathy.
- Major surgery within 28 days before first dose or planned during study.
- History of organ transplant requiring ongoing immunosuppressants.
- Acute infections within 14 days before first dose requiring intravenous therapy.
- Received autologous stem cell transplant within 12 weeks or allogeneic stem cell transplant within 1 year before first dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, Florida, United States, 33136
Actively Recruiting
2
Boston Medical Center /ID# 255066
Boston, Massachusetts, United States, 02118
Actively Recruiting
3
Mayo Clinic - Rochester /ID# 255258
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, New York, United States, 10029
Actively Recruiting
5
Columbia University Medical Center /ID# 255068
New York, New York, United States, 10032-3729
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, New York, United States, 10065-6007
Actively Recruiting
7
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, North Carolina, United States, 28204
Actively Recruiting
8
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
9
Oregon Medical Research Center /ID# 255119
Portland, Oregon, United States, 97239
Actively Recruiting
10
Vanderbilt University Medical Center. /ID# 273510
Nashville, Tennessee, United States, 37232
Actively Recruiting
11
University of Washington /ID# 261581
Seattle, Washington, United States, 98109
Actively Recruiting
12
Wisconsin Medical Center /ID# 255836
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
Westmead Hospital /ID# 255200
Westmead, New South Wales, Australia, 2145
Actively Recruiting
14
Princess Alexandra Hospital /ID# 255202
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
15
Box Hill Hospital /ID# 255199
Box Hill, Victoria, Australia, 3128
Actively Recruiting
16
CHU Limoges - Dupuytren 1 /ID# 255370
Limoges, Franche-Comte, France, 87042
Actively Recruiting
17
CHU Toulouse - Hopital Rangueil /ID# 255377
Toulouse, Haute-Garonne, France, 31400
Actively Recruiting
18
Alexandra General Hospital /ID# 255542
Athens, Attica, Greece, 11528
Actively Recruiting
19
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654
Bologna, Italy, 40138
Actively Recruiting
20
Fondazione IRCCS Policlinico San Matteo /ID# 255655
Pavia, Italy, 27100
Actively Recruiting
21
Nagoya City University Hospital /ID# 256086
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
22
Kumamoto University Hospital /ID# 262579
Kumamoto, Kumamoto, Japan, 8608556
Actively Recruiting
23
Japanese Red Cross Medical Center /ID# 256083
Shibuya-ku, Tokyo, Japan, 150-8935
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here