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. 2023 Jan 13;19(1):7–17. doi: 10.2217/fon-2022-0975

Table 1. . Key eligibility criteria.

Key inclusion criteria
Male or female aged ≥18 years
Previous diagnosis of MM based on the IMWG 2016 criteria and currently requiring treatment
Measurable disease, defined as ≥1 of the following: serum M-protein ≥0.5 g/dl (≥5 g/l), urine M-protein ≥200 mg/24 h, SFLC assay with involved SFLC level ≥10 mg/dl (100 mg/l) and abnormal SFLC ratio
ECOG performance status ≤2
Received ≥3 previous lines of therapy, including an IMiD and a PI
Daratumumab arm: CD38+ MM with no prior anti-CD38 antibody therapy for ≤6 months prior to enrollment; no history of discontinuation of daratumumab due to toxicity
Pomalidomide/dexamethasone arm: no history of pomalidomide discontinuation due to toxicity; prior pomalidomide therapy allowed if PR was achieved with the most recent pomalidomide therapy and pomalidomide-free interval since last dose is ≥6 months; no contraindication to dexamethasone
Carfilzomib/dexamethasone arm: no history of discontinuation of carfilzomib due to toxicity; prior PI therapy allowed if PR was achieved with the most recent PI therapy; no contraindication to dexamethasone
Bortezomib/dexamethasone arm: no history of discontinuation of bortezomib due to toxicity; prior PI therapy allowed if PR was achieved with the most recent PI therapy and PI-free interval since last dose is ≥6 months; no contraindication to dexamethasone; if initiated, patients only require one prior line of therapy
Key exclusion criteria
Prior treatment with CD47- or SIRPα-targeting agents
MM of immunoglobulin M subtype, Waldenström macroglobulinemia, or MDS
Known amyloidosis, including myeloma complicated by amyloidosis
Plasma cell leukemia or circulating plasma cells ≥2 × 109/l
Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
POEMS syndrome
Glucocorticoid therapy within 14 days prior to enrollment
Chemotherapy with approved or investigational anticancer therapies within 28 days prior to enrollment
Focal radiation therapy within 7 days prior to enrollment; radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment
Immunotherapy within 28 days prior to enrollment
Autologous SCT <100 days prior to enrollment or considered eligible to receive autologous or allogeneic SCT at the time of enrollment

ECOG: Eastern Cooperative Oncology Group; IMiD: Immunomodulatory drug; IMWG: International Myeloma Working Group; MDS: Myelodysplastic syndrome; MM: Multiple myeloma; PI: Proteasome inhibitor; POEMS: Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes; PR: Partial response; SCT: Stem cell transplant; SFLC: Serum free light chain.