Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/7/23. Questions regarding updates should be directed to the study team contact.