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
2026년 8월 26일 업데이트: AbbVie
A Phase 3 Multicenter, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) Compared to Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (Dara-CyBorD) in Subjects With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
370
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red-stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance.
- Evidence of a monoclonal plasma cell proliferative disorder (serum or urine monoclonal protein, abnormal free light-chain ratio, or clonal plasma cells in the bone marrow).
- Measurable disease of amyloid light chain (AL) amyloidosis as defined by difference in free light chains (dFLC) >= 50 mg/L
- No history of treatment with anti-amyloidosis therapy.
- Presence of an amyloid-related systemic syndrome with at least 1 organ impacted by AL amyloidosis according to International Myeloma Working Group (IMWG) diagnostic criteria.
- Considered AL amyloidosis cardiac risk stage 1, 2, or 3a (or 3b [randomized portion only]).
- Eastern Cooperative Oncology Group performance status <= 2.
Exclusion Criteria:
- Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatments.
- Active hepatitis B or hepatitis C infection.
- History of other active malignancies within the past 3 years (with specified exceptions).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Safety Run-in: Etentamig
Participants receive etentamig, as part of a 96 month study duration.
|
Injection
|
|
실험적: Randomized Portion: Etentamig
Participants will receive etentamig , as part of a 96 month study duration.
|
Injection
|
|
활성 비교기: Daratumumab + Cyclophosphamide + Bortezomib + Dexamethasone
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..
|
주입
경구
Oral
Injection
Infusion
Infusion
Infusion
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Adverse Events
기간: Up to Approximately 96 Months
|
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.
|
Up to Approximately 96 Months
|
|
Randomized Portion: Complete Hematologic Response (HemeCR) Rate
기간: Up to Approximately 60 Months
|
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)
|
Up to Approximately 60 Months
|
|
Randomized Portion: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
기간: Up to Approximately 60 Months
|
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.
|
Up to Approximately 60 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety Run-In: Major Organ Deterioration Progression-Free Survival (MOD-PFS)
기간: Up to Approximately 60 Months
|
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.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Overall Survival (OS)
기간: Up to Approximately 60 Months
|
Overall survival defined as the time from randomization to death from any cause.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Percentage of Participants With Hematologic Very Good Partial Response (VGPR) or Better
기간: Up to Approximately 60 Months
|
Percentage of participants achieving hematologic very good partial response or better based on International Amyloidosis Consensus Criteria.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Cardiac Response Rate
기간: Up to Approximately 60 Months
|
Percentage of participants achieving cardiac response as assessed per graded criteria.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Renal Response Rate
기간: Up to Approximately 60 Months
|
Percentage of participants achieving renal response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Liver Response Rate
기간: Up to Approximately 60 Months
|
Percentage of participants achieving liver response as assessed per the International Amyloidosis Consensus Criteria (IACC) criteria.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Next Treatment
기간: Up to Approximately 60 Months
|
Time from randomization to initiation of next anti-AL amyloidosis treatment.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Complete Hematologic Response
기간: Up to Approximately 60 Months
|
Time from randomization to first documentation of complete hematologic response (hemeCR) as determined by International Amyloidosis Criteria Committee.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Duration of Complete Hematologic Response
기간: Up to Approximately 60 Months
|
Duration of complete hematologic response (hemeCR) defined as the time from first documentation of hemeCR to the date of loss of hemeCR.
|
Up to Approximately 60 Months
|
|
Randomized Portion: Time to Cardiac Response
기간: Up to Approximately 60 Months
|
Time from randomization to first achievement of cardiac response.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Renal Response
기간: Up to Approximately 60 Months
|
Time from randomization to first achievement of renal response.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Liver Response
기간: Up to Approximately 60 Months
|
Time from randomization to first achievement of liver response.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Duration of Cardiac Response
기간: Up to Approximately 60 Months
|
Time from first achievement of cardiac response to cardiac progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Duration of Renal Progression
기간: Up to Approximately 60 Months
|
Time from first achievement of renal response to renal progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Duration of Liver Response
기간: Up to Approximately 60 Months
|
Time from first achievement of liver response to liver progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Cardiac Progression
기간: Up to Approximately 60 Months
|
Time from randomization to first occurrence of cardiac progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Renal Progression
기간: Up to Approximately 60 Months
|
Time from randomization to first occurrence of renal progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Liver Progression
기간: Up to Approximately 60 Months
|
Time from randomization to first occurrence of liver progression.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Maximum Serum Concentration (Cmax) of Etentamig
기간: Up to Approximately 60 Months
|
Cmax of etentamig.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Time to Maximum Serum Concentration (Tmax) of Etentamig
기간: Up to Approximately 60 Months
|
Tmax of etentamig.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Area Under the Concentration-Time Curve (AUC) of Etentamig
기간: Up to Approximately 60 Months
|
AUC of etentamig.
|
Up to Approximately 60 Months
|
|
Safety Run-In and Randomized Portion: Percentage of Participants With Anti-Drug Antibodies (ADA)
기간: Up to Approximately 60 Months
|
Immunogenicity assessed through summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antidrug antibodies (NAbs), if NAbs samples are analyzed.
|
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
기간: Up to Approximately 60 Months
|
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains.
Higher scores indicate better health status.
|
Up to Approximately 60 Months
|
|
Randomized Portion: Change from Baseline in Mental Functioning as Measured by SF-36 v2 Mental Component Summary Score
기간: Up to Approximately 60 Months
|
The SF-36 v2 is a 36-item questionnaire measuring health-related quality of life across eight domains.
Higher scores indicate better health status.
|
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
기간: Up to Approximately 60 Months
|
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life.
Higher scores indicate worse symptoms.
|
Up to Approximately 60 Months
|
|
Randomized Portion: Change from Baseline in Fatigue as Measured by EORTC QLQ-C30 Fatigue Scale Score
기간: Up to Approximately 60 Months
|
The EORTC QLQ-C30 is a 30-item questionnaire assessing cancer-specific quality of life.
Higher scores indicate worse symptoms.
|
Up to Approximately 60 Months
|
|
Randomized Portion: Change from Baseline in Disease Symptoms as Measured by Additional EORTC Questionnaire Symptom Scales/Items
기간: Up to Approximately 60 Months
|
The EORTC questionnaires assess cancer-specific symptoms and quality of life.
|
Up to Approximately 60 Months
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 29일
기본 완료 (추정된)
2034년 12월 1일
연구 완료 (추정된)
2034년 12월 1일
연구 등록 날짜
최초 제출
2026년 8월 26일
QC 기준을 충족하는 최초 제출
2026년 8월 26일
처음 게시됨 (실제)
2026년 8월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신생물
- 대사 질환
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 림프 증식 장애
- 면역증식성 장애
- 신생물, 형질세포
- 파라단백혈증
- 단백질 결핍증
- 영양 및 대사 질환
- 면역글로불린 경쇄 아밀로이드증
- 아밀로이드증
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 탄화수소
- 다 환식 화합물
- 무기 화학 물질
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- 포스 포 아미드 머스타드
- 질소 머스타드 화합물
- 겨자 화합물
- 탄화수소, 할로겐화
- 포스 포 아미드
- 유기 인 화합물
- Pregnadienetriols
- 보 론산
- 산, 비 카르 복실
- 산
- 붕소 화합물
- 피라진
- 보르테조밉
- 덱사메타손
- 시클로포스파미드
- 다라 토무 맙
기타 연구 ID 번호
- M24-473
- 2026-525253-37-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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아니
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