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

Launched by ABBVIE · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-383 for adults with a condition known as immunoglobulin light chain (AL) amyloidosis. AL amyloidosis happens when certain proteins build up in the body and can damage organs. The researchers want to see how effective ABBV-383 is in reducing disease activity and to monitor any side effects that may occur. The trial is divided into two parts: the first part will test different doses of the drug to find the best one, and the second part will focus on confirming the safety of those doses in a larger group of participants. About 76 adults who have had treatment for AL amyloidosis that didn’t work will be enrolled in the study at around 20 locations worldwide.

To be eligible for the trial, participants need to have a confirmed diagnosis of AL amyloidosis and have experienced problems with at least one organ due to the disease. They should also have previously been treated with certain medications called proteasome inhibitors and anti-CD38 monoclonal antibodies. During the trial, participants will receive the drug through an intravenous infusion, which means it will be given through a vein. They will need to visit a hospital or clinic regularly for medical check-ups, blood tests, and to report any side effects. It’s important to know that participating in this trial may require more time and commitment compared to standard treatment.

Gender

ALL

Eligibility 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 risk stage 1, 2, or 3a and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L.
• • 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 drugs (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 drug treatment.