Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety and tolerability assessed through adverse events, laboratory tests, vital signs, physical examinations, and other safety assessments.

HemeCR rate is defined as the proportion of subjects with the best overall response of hemeCR as determined by International Amyloidosis Consensus Criteria (IACC) and assessed by the independent review committee (IRC)

MOD-PFS is defined as the time from the date of randomization to the date of MOD-PFS event or death from any cause, whichever occurs first. MOD-PFS includes: Development of hematologic progressive disease per consensus guidelines or high-risk difference in free light chain (dFLC) progression; Clinical manifestation of cardiac failure (defined as need for cardiac transplant, left ventricular assist device, or intra-aortic balloon pump); Clinical manifestation of renal failure (defined as development of end-stage renal disease needing hemodialysis or renal transplant); Death. MOD-PFS will be assessed by an Independent Review Committee.

MOD-PFS is defined as the time from the date of randomization to the date of MOD-PFS event or death from any cause, whichever occurs first. MOD-PFS includes: Development of hematologic progressive disease per consensus guidelines or high-risk difference in free light chain (dFLC) progression; Clinical manifestation of cardiac failure (defined as need for cardiac transplant, left ventricular assist device, or intra-aortic balloon pump); Clinical manifestation of renal failure (defined as development of end-stage renal disease needing hemodialysis or renal transplant); Death.

Overall survival defined as the time from randomization to death from any cause.

Percentage of participants achieving hematologic very good partial response or better based on International Amyloidosis Consensus Criteria.

Percentage of participants achieving cardiac response as assessed per graded criteria.

Percentage of participants achieving renal response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.

Percentage of participants achieving liver response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.

Time from randomization to initiation of next anti-AL amyloidosis treatment.

Time from randomization to first documentation of complete hematologic response (hemeCR) as determined by International Amyloidosis Criteria Committee.

Duration of complete hematologic response (hemeCR) defined as the time from first documentation of hemeCR to the date of loss of hemeCR.

Time from randomization to first achievement of cardiac response.

Time from randomization to first achievement of renal response.

Time from randomization to first achievement of liver response.

Time from first achievement of cardiac response to cardiac progression.

Time from first achievement of renal response to renal progression.

Time from first achievement of liver response to liver progression.

Time from randomization to first occurrence of cardiac progression.

Time from randomization to first occurrence of renal progression.

Time from randomization to first occurrence of liver progression.

Cmax of etentamig.

Tmax of etentamig.

AUC of etentamig.

Immunogenicity assessed through summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antidrug antibodies (NAbs), if NAbs samples are analyzed.

The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.

The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.

The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.

The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.

The EORTC questionnaires assess cancer-specific symptoms and quality of life.