An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Number of Participants With Adverse Effects (AEs)

时间窗: From initiation of study treatment up to approximately 15.7 months

AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading

时间窗: From initiation of study treatment up to approximately 15.7 months

CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, headache, and myalgia and may also include hypotension, capillary leak (hypoxia), dyspnea, chest discomfort and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.

Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading

时间窗: From initiation of study treatment up to approximately 15.7 months

ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging.

Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria

时间窗: Up to approximately 15.2 months

ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas.

Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria

时间窗: Up to approximately 15.2 months

CRR and sCRR were defined as the percentage of participants with CR or sCR, as determined by the investigator per IMWG response criteria. CR was defined as: no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum \& urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells in BM \& a normal SFLC ratio of 0.26-1.65. sCR was defined as: CR (defined above); normal SFLC ratio, \& absence of clonal cells in BM by IHC or negative by 2-4 color flow cytometry. CR and sCR are distinct response categories and are evaluated and reported separately in accordance with the defined response criteria i.e., if a response is clinically upgraded from CR to sCR it is not further considered a CR but solely a sCR. Percentages have been rounded off.

Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria

时间窗: Up to approximately 15.2 months

VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off.

Percentage of Participants with Adverse Events (AEs)

时间窗: Up to approximately 24 months

Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria

时间窗: Up to approximately 24 months

Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria

时间窗: Up to approximately 24 months

Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria

时间窗: Up to approximately 24 months