Clinical Trials

Inclusion Criteria:

- Age ≥ 18 years at time of signing Informed Consent Form

- Ability to comply with the study protocol, in the investigator's judgment

- Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or
immunohistochemistry (IHC) on a tissue biopsy

- Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation
38 (CD 38) monoclonal antibody

- Participants with a history of autologous hematopoietic cell transplantation must have
recovered from any transplant-related toxicities

- Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed
by FISH testing at Columbia University Irving Medical Center (CUIMC)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Known hypersensitivity to any of the study drugs

- History of other malignancy that could affect compliance with the protocol or
interpretation of results (Patients with a history of curatively treated basal or
squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer,
or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been
treated, but not with curative intent, will be excluded, unless the malignancy has
been in remission without treatment for ≥ 2 years prior to enrollment.)

- Evidence of other clinically significant uncontrolled condition(s) including, but not
limited to, uncontrolled systemic infection (viral, bacterial, or fungal)

- Patients on renal replacement therapy

- Known GI disease or GI procedure that could interfere with oral absorption (including
difficulty swallowing)

- New York Heart Association (NYHA) Class III or IV heart failure

- Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide
(NT-Pro BNP) > 8500 pg/mL

- Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors

- Patients with human immunodeficiency virus (HIV) who are not on highly active
antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection

- Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a)
Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate
etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%

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

Eligibility last updated 12/1/22. Questions regarding updates should be directed to the study team contact.