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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

2026년 7월 22일 업데이트: AbbVie

A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.

Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.

Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 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

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

520

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 네덜란드
    • South Holland
      • Leiden, South Holland, 네덜란드, 2333 ZA
        • Leids Universitair Medisch Centrum /ID# 283142
      • Rotterdam, South Holland, 네덜란드, 3015 CE
        • Erasmus Medisch Centrum /ID# 283408
  • 노르웨이
    • Sogn Og Fjordane
      • Bergen, Sogn Og Fjordane, 노르웨이, 5021
        • Haukeland University Hospital /ID# 283524
  • 대만
      • Kaohsiung City, 대만, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 282970
  • 독일
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, 독일, 79106
        • Universitaetsklinikum Freiburg /ID# 282874
      • Karlsruhe, Baden-Wurttemberg, 독일, 76133
        • Staedtisches Klinikum Karlsruhe /ID# 283569
      • Tübingen, Baden-Wurttemberg, 독일, 72076
        • Universitaetsklinikum Tuebingen /ID# 282873
      • Ulm, Baden-Wurttemberg, 독일, 89081
        • Universitaetsklinikum Ulm /ID# 283884
    • Bavaria
      • Würzburg, Bavaria, 독일, 97080
        • Universitaetsklinikum Wuerzburg /ID# 283572
    • Lower Saxony
      • Hanover, Lower Saxony, 독일, 30459
        • Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, 독일, 53127
        • Universitaetsklinikum Bonn /ID# 283881
      • Cologne, North Rhine-Westphalia, 독일, 50937
        • Universitaetsklinikum Koeln /ID# 283930
  • 미국
    • Arizona
      • Tucson, Arizona, 미국, 85704
        • University of Arizona Cancer Center /ID# 285339
    • California
      • Cerritos, California, 미국, 90703
        • Toi Clinical Research - Whittier /ID# 284462
      • Los Angeles, California, 미국, 90095-3075
        • University of California Los Angeles /ID# 282444
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • University Of Colorado - Anschutz Medical Campus /ID# 283478
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20007
        • MedStar Georgetown University Hospital /ID# 283734
    • Florida
      • Weston, Florida, 미국, 33331
        • Cleveland Clinic Florida /ID# 283692
    • Georgia
      • Marietta, Georgia, 미국, 30060
        • Northwest Georgia Oncology Centers /ID# 284769
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center /ID# 283095
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Medical Center /ID# 285204
    • Michigan
      • Grand Rapids, Michigan, 미국, 49503
        • Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
    • New York
      • New York, New York, 미국, 10029
        • The Mount Sinai Hospital /ID# 283535
      • New York, New York, 미국, 10032
        • Columbia University Medical Center /ID# 283510
      • New York, New York, 미국, 10065
        • Weill Cornell Medicine - Cornell University /ID# 283712
      • Rochester, New York, 미국, 14642
        • University of Rochester Medical Center /ID# 283480
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center /ID# 283475
      • Winston-Salem, North Carolina, 미국, 27103
        • Novant Health Forsyth Medical Center /ID# 283485
    • Ohio
      • Cleveland, Ohio, 미국, 44106
        • University Hospitals Cleveland Medical Center /ID# 283527
    • Oregon
      • Portland, Oregon, 미국, 97239
        • Oregon Health and Science University /ID# 282023
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • SCRI Oncology Partners /ID# 281380
    • Texas
      • Houston, Texas, 미국, 77030-4000
        • MD Anderson Houston /ID# 282622
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute /ID# 283512
    • Virginia
      • Richmond, Virginia, 미국, 23298
        • VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792
        • University of Wisconsin Hospitals and Clinics /ID# 282516
  • 스페인
      • Madrid, 스페인, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 283342
    • Cantabria
      • Santander, Cantabria, 스페인, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 283344
    • Navarre
      • Pamplona, Navarre, 스페인, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 283290
  • 영국
    • Devon
      • Plymouth, Devon, 영국, PL6 8DH
        • University Hospitals Plymouth NHS Trust /ID# 283108
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, 영국, EH4 2XU
        • Western General Hospital - NHS Lothian /ID# 281838
    • Greater London
      • London, Greater London, 영국, EC1A 7BE
        • St Bartholomews Hospital - Barts Health /ID# 283714
    • Hampshire
      • Portsmouth, Hampshire, 영국, PO6 3LY
        • Queen Alexandra Hospital /ID# 281839
    • North Lanarkshire
      • Airdrie, North Lanarkshire, 영국, ML6 0JS
        • NHS Lanarkshire /ID# 282021
    • Nottinghamshire
      • Nottingham, Nottinghamshire, 영국, NG5 1PB
        • Nottingham City Hospital /ID# 282748
  • 이탈리아
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, 이탈리아, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
  • 캐나다
    • British Columbia
      • Victoria, British Columbia, 캐나다, V8R 6V5
        • British Columbia Cancer Agency Vancouver Centre /ID# 282147
    • Ontario
      • London, Ontario, 캐나다, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
    • Quebec
      • Montreal, Quebec, 캐나다, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
  • 포르투갈
      • Braga, 포르투갈, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 283828
      • Porto, 포르투갈, 4200-319
        • Unidade Local de Saude Sao Joao /ID# 283530
    • Lisbon District
      • Lisbon, Lisbon District, 포르투갈, 1449-005
        • Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
    • Porto District
      • Vila Nova de Gaia, Porto District, 포르투갈, 4434-502
        • Unidade Local de Saude de Gaia/Espinho /ID# 283492
  • 프랑스
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, 프랑스, 06202
        • Chu de Nice-Hopital Larchet Ii /Id# 283541
    • Indre-et-Loire
      • Tours, Indre-et-Loire, 프랑스, 37044
        • CHRU Tours - Hopital Bretonneau /ID# 281925
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 프랑스, 54511
        • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, 프랑스, 44000
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, 프랑스, 84000
        • Centre Hospitalier d'Avignon /ID# 283509
  • 헝가리
    • Vas County
      • Szombathely, Vas County, 헝가리, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
  • 호주
    • New South Wales
      • Wollongong, New South Wales, 호주, 2500
        • Wollongong Hospital. /ID# 282694
    • Queensland
      • Benowa, Queensland, 호주, 4217
        • Pindara Private Hospital /ID# 283010
      • South Brisbane, Queensland, 호주, 4101
        • Icon Cancer Care - South Brisbane /ID# 282965
    • Victoria
      • Melbourne, Victoria, 호주, 3000
        • Peter MacCallum Cancer Centre. /ID# 282692
      • Richmond, Victoria, 호주, 3121
        • Epworth Hospital - Richmond /ID# 281877
    • Western Australia
      • Murdoch, Western Australia, 호주, 6150
        • Fiona Stanley Hospital /ID# 281879
      • Nedlands, Western Australia, 호주, 6009
        • Sir Charles Gairdner Hospital /ID# 281881

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:

  • Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
  • Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
  • Adequate organ function and performance status

Exclusion Criteria:

  • Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
  • Known central nervous system involvement of MM
  • Known history of other active malignancies within the past 3 years (with specific exceptions)
  • Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)

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: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
의약품: Etentamig
Injection
의약품: Pomalidomide
Oral
실험적: Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
의약품: Etentamig
Injection
의약품: Pomalidomide
Oral
활성 비교기: Randomized Portion: Standard Available Therapy (SAT)
Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
의약품: 다라투무맙
주입
의약품: 카르필조밉
주입
의약품: Dexamethasone
Oral or Injection
의약품: Teclistamab
Injection

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety Run-In: Number of Participants With Adverse Events (AE)s
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
기간: Up to Approximately 75 Months
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).
Up to Approximately 75 Months
Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months

2차 결과 측정

결과 측정
측정값 설명
기간
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
기간: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Time to Cmax (Tmax) of Etentamig
기간: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
기간: Up to Approximately 12 Months
Cmax of Etentamig.
Up to Approximately 12 Months
Safety Run-In: Immunogenicity of Etentamig
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Overall Survival (OS)
기간: Up to Approximately 75 Months
Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.
Up to Approximately 75 Months
Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity
기간: Up to Approximately 75 Months
Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment
기간: Up to Approximately 75 Months
Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: BOR Per IRC Assessment
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: VGPR or Better Rate Per IRC Assessment
기간: Up to Approximately 75 Months
VGPR or better rate per IRC assessment, defined as percentage of participants achieving VGPR, CR, or sCR using IMWG (2016) response criteria.
Up to Approximately 75 Months
Randomized Portion: Time to Response (TTR) Per IRC Assessment
기간: Up to Approximately 75 Months
TTR is defined as the time from randomization to first documented response (PR or better) per IRC assessment using IMWG (2016) response criteria.
Up to Approximately 75 Months
Randomized Portion: Duration of Response (DOR) Per IRC Assessment
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Second Progression-Free Survival (PFS2)
기간: Up to Approximately 75 Months
PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.
Up to Approximately 75 Months
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months
Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment
기간: Up to Approximately 75 Months
EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: Time to Next Treatment (TTNT)
기간: Up to Approximately 75 Months
TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.
Up to Approximately 75 Months
Randomized Portion: Time to Symptomatic Disease Progression
기간: Up to Approximately 75 Months
Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).
Up to Approximately 75 Months
Randomized Portion: Change From Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma Module (EORTC QLQ-MY20)
기간: Up to Approximately 75 Months
Change from baseline in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 .
Up to Approximately 75 Months
Randomized Portion: Change From Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
기간: Up to Approximately 75 Months
Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30.
Up to Approximately 75 Months
Randomized Portion: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 (FACT-G GP5)
기간: Up to Approximately 75 Months
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.
Up to Approximately 75 Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

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 30일

기본 완료 (추정된)

2033년 2월 1일

연구 완료 (추정된)

2033년 2월 1일

연구 등록 날짜

최초 제출

2026년 7월 22일

QC 기준을 충족하는 최초 제출

2026년 7월 22일

처음 게시됨 (실제)

2026년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 22일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • M22-538
  • 2026-525596-11-00 (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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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