A Phase 3 interventional study of Etentamig and Daratumumab in Amyloid Light Chain (AL) Amyloidosis, sponsored by AbbVie. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in organs, leading to organ dysfunction and failure. The goal of this study is to evaluate the safety and efficacy of etentamig compared to daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in participants with newly diagnosed AL amyloidosis.
Etentamig is an investigational drug being developed for the treatment of newly diagnosed AL amyloidosis. This is an open-label study. The study consists of 2 parts: a Safety Run-in where participatns will receive etentamig, and a Randomized Portion with 2 treatment arms where participants will receive etentamig, or Dara-CyBorD. Approximately 370 participants will be enrolled in the study at approximately 130 sites worldwide.
Participants will receive injected etentamig, in the Safety Run-in. Participants will receive injected etentamig, or Dara-CyBorD per the local label, in the Randomized Portion of the study. The total study duration is approximately 96 months.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Exclusion Criteria:
Participants receive etentamig, as part of a 96 month study duration.
Drug: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
Drug: Etentamig
Participants will receive daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in accordance with the local approved label, as part of a 96 month study duration..
Drug: Daratumumab · Drug: Cyclophosphamide · Drug: Bortezomib · Drug: Dexamethasone
Injection
Injection
Oral
Injection
Oral
Infusion
Infusion
Infusion
Number of Participants With Adverse Events
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.
Time frame: Up to Approximately 96 Months
Randomized Portion: Complete Hematologic Response (HemeCR) Rate
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)
Time frame: Up to Approximately 60 Months
Randomized Portion: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
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.
Time frame: Up to Approximately 60 Months
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
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.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Overall Survival (OS)
Overall survival defined as the time from randomization to death from any cause.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Percentage of Participants With Hematologic Very Good Partial Response (VGPR) or Better
Percentage of participants achieving hematologic very good partial response or better based on International Amyloidosis Consensus Criteria.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Cardiac Response Rate
Percentage of participants achieving cardiac response as assessed per graded criteria.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Renal Response Rate
Percentage of participants achieving renal response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Liver Response Rate
Percentage of participants achieving liver response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Next Treatment
Time from randomization to initiation of next anti-AL amyloidosis treatment.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Complete Hematologic Response
Time from randomization to first documentation of complete hematologic response (hemeCR) as determined by International Amyloidosis Criteria Committee.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Complete Hematologic Response
Duration of complete hematologic response (hemeCR) defined as the time from first documentation of hemeCR to the date of loss of hemeCR.
Time frame: Up to Approximately 60 Months
Randomized Portion: Time to Cardiac Response
Time from randomization to first achievement of cardiac response.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Renal Response
Time from randomization to first achievement of renal response.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Liver Response
Time from randomization to first achievement of liver response.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Cardiac Response
Time from first achievement of cardiac response to cardiac progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Renal Progression
Time from first achievement of renal response to renal progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Duration of Liver Response
Time from first achievement of liver response to liver progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Cardiac Progression
Time from randomization to first occurrence of cardiac progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Renal Progression
Time from randomization to first occurrence of renal progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Liver Progression
Time from randomization to first occurrence of liver progression.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Maximum Serum Concentration (Cmax) of Etentamig
Cmax of etentamig.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Time to Maximum Serum Concentration (Tmax) of Etentamig
Tmax of etentamig.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Area Under the Concentration-Time Curve (AUC) of Etentamig
AUC of etentamig.
Time frame: Up to Approximately 60 Months
Safety Run-In and Randomized Portion: Percentage of Participants With Anti-Drug Antibodies (ADA)
Immunogenicity assessed through summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antidrug antibodies (NAbs), if NAbs samples are analyzed.
Time frame: Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Physical Functioning as Measured by 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary Score
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.
Time frame: Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Mental Functioning as Measured by SF-36 v2 Mental Component Summary Score
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains. Higher scores indicate better health status.
Time frame: Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.
Time frame: Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Fatigue as Measured by EORTC QLQ-C30 Fatigue Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life. Higher scores indicate worse symptoms.
Time frame: Up to Approximately 60 Months
Randomized Portion: Change from Baseline in Disease Symptoms as Measured by Additional EORTC Questionnaire Symptom Scales/Items
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
Time frame: Up to Approximately 60 Months
No study locations are listed for this record.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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