Clinical Trials

Inclusion Criteria:

- Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or
free light chain) per International Myeloma Working Group (IMWG) criteria, including
non-secretory or oligo-secretory multiple myeloma which has relapsed after or is
refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators
(IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).

- Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1
or less (for France).

- Adequate hematologic, renal, and hepatic functions

- Seronegative for hepatitis B antigen; positive hepatitis B tests can be further
evaluated by confirmatory tests, and if viral load is negative, the subject can be
enrolled.

- Seronegative for hepatitis C antibody; if positive, then further test for the presence
of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen
tests are negative, then the subject can be enrolled.

- Oxygen saturation level ≥92% on room air.

- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion
at Screening

Exclusion Criteria:

- Active central nervous system involvement

- Exposure to daratumumab or isatuximab within 2 months prior to the start of study
treatment

- Active plasma cell leukemia

- Active infectious disease

- Clinically significant cardiovascular and respiratory conditions

- History of HIV infection

- Subjects requiring prohibited concomitant medications

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

Eligibility last updated 8/11/22. Questions regarding updates should be directed to the study team contact.