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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 po

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • ABBV-383 (Etentamig)
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Where

23 sites
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, United States
Boston Medical Center /ID# 255066
Boston, United States
Mayo Clinic - Rochester /ID# 255258
Rochester, United States
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, United States
Columbia University Medical Center /ID# 255068
New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, United States
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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