Inclusion Criteria:
- Age ≥ 18 years
- Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory
disease. Participants must have confirmed progressive disease (as per IMWG criteria)
on or within 12 months of completing treatment with the last anti-myeloma treatment
regimen before study entry or have confirmed progressive disease within 6 months prior
to screening and who are subsequently determined to be refractory or non-responsive to
their most recent anti-myeloma treatment regimen, except for participants with
cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last
treatment, who may enroll beyond 12 months.
- Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at
least 3 prior anti-myeloma treatment regimens (note: induction with or without
hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is
considered one regimen).Subjects in Part B Cohort C only must have received at least 1
but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome
inhibitor and immunomodulatory agent including:
- Autologous HSCT, unless the subject was ineligible
- A regimen that included an immunomodulatory agent (e.g., thalidomide,
lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib,
carfilzomib, ixazomib), either alone or combination
- Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C
do not require prior anti-CD38 antibody therapy.
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Known active or history of central nervous system (CNS) involvement of MM
- Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS
(polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes)
syndrome, or clinically significant amyloidosis
- Active autoimmune disease requiring immunosuppressive therapy
- History or presence of clinically significant CNS pathology such as seizure disorder,
aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar
disease, or psychosis
Other protocol-defined inclusion/exclusion criteria apply.
Active, Not Recruiting
