A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma

AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria. CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates. The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).

PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.

BOR is defined as the best response achieved across all response assessments, partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR), from randomization until disease progression per investigator assessment, using IMWG (2016) response criteria.

Cmax of Etentamig.

Cmax of Etentamig.

Cmax of Etentamig.

Immunogenicity of etentamig is defined as the summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antibody (NAb)s, if NAb samples are analyzed.

MRDnegCR is defined as achievement of CR or better by IMWG (2016) response criteria per IRC assessment and MRD negative status as assessed by next-generation sequencing (NGS) at threshold defined in the protocol.

Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.

Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).

Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).

BOR is defined as the best response achieved across all response assessments, PR + VGPR + CR +sCR from randomization until disease progression per IRC assessment, using IMWG (2016) response criteria.

VGPR or better rate per IRC assessment, defined as percentage of participants achieving VGPR, CR, or sCR using IMWG (2016) response criteria.

TTR is defined as the time from randomization to first documented response (PR or better) per IRC assessment using IMWG (2016) response criteria.

DOR is defined as the time from first documented response (PR or better) to disease progression or death, whichever occurs first, per IRC assessment using IMWG (2016) response criteria.

PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.

Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life score. Patient-reported outcome (PRO) assessment.

EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).

TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.

Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).

Change from baseline in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 .

Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30.

Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 FACT-G GP5. Patient-reported outcome (PRO) assessment.