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New treatment option for Immunoglobulin Light Chain (AL) Amyloidosis
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
ClinicalTrials.gov ID: NCT06158854
What this study is testing
What is ABBV-383 (Etentamig)?
ABBV-383 (Etentamig) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for immunoglobulin light chain (al) amyloidosis.
Also referred to as TNB-383B.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
You likely can't join if
- 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...
- 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...
- Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential);
See the full eligibility 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...
- Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
- 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 \>...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Westmead, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Box Hill, Victoria, Australia
- Limoges, Franche-Comte, France
- Toulouse, Haute-Garonne, France
- Athens, Attica, Greece
- Bologna, Italy
- Pavia, Italy
- Nagoya, Aichi-ken, Japan
- Kumamoto, Kumamoto, Japan
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; New York, New York, United States; Charlotte, North Carolina, United States; Winston-Salem, North Carolina, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.