Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.
Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.
In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
Serum M-protein >= 0.5 g/dL (>= 5 g/L).
Urine M-protein >= 200 mg/24 hours.
Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
Central nervous system involvement of MM.
Has received B-cell maturation antigen (BCMA)-targeted therapy.
Parallel
Etentamig
DrugIntravenous (IV) Infusion
Carfilzomib
DrugIV Infusion
Pomalidomide
DrugOral Capsule
Elotuzumab
DrugIV Infusion
Selinexor
DrugOral Tablet
Bortezomib
DrugSubcutaneous or IV Injection
Dexamethasone
DrugOral Tablet or IV Infusion
Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
Overall Survival (OS)
OS is defined as the duration from the date of randomization to the date of the participant's death.
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
The rate of \>= VGPR is defined as the proportion of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new myeloma therapy.
Change in Rate of CR or Better (>=CR)
\>=CR is defined as the percentage of participants who achieve confirmed CR + sCR or per IRC assessment.
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
MRD negativity with \>= CR, 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) Adaptive Clonoseq at 10\^-5 threshold.
