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
2026年7月22日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
520
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85704
- University of Arizona Cancer Center /ID# 285339
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California
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Cerritos、California、アメリカ、90703
- Toi Clinical Research - Whittier /ID# 284462
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Los Angeles、California、アメリカ、90095-3075
- University of California Los Angeles /ID# 282444
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Colorado
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Aurora、Colorado、アメリカ、80045
- University Of Colorado - Anschutz Medical Campus /ID# 283478
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital /ID# 283734
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Florida
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Weston、Florida、アメリカ、33331
- Cleveland Clinic Florida /ID# 283692
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Georgia
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Marietta、Georgia、アメリカ、30060
- Northwest Georgia Oncology Centers /ID# 284769
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Illinois
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Chicago、Illinois、アメリカ、60612
- Rush University Medical Center /ID# 283095
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center /ID# 285204
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Michigan
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Grand Rapids、Michigan、アメリカ、49503
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
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New York
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New York、New York、アメリカ、10029
- The Mount Sinai Hospital /ID# 283535
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New York、New York、アメリカ、10032
- Columbia University Medical Center /ID# 283510
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New York、New York、アメリカ、10065
- Weill Cornell Medicine - Cornell University /ID# 283712
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Rochester、New York、アメリカ、14642
- University of Rochester Medical Center /ID# 283480
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center /ID# 283475
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Winston-Salem、North Carolina、アメリカ、27103
- Novant Health Forsyth Medical Center /ID# 283485
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Ohio
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Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center /ID# 283527
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University /ID# 282023
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- SCRI Oncology Partners /ID# 281380
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Texas
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Houston、Texas、アメリカ、77030-4000
- MD Anderson Houston /ID# 282622
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Utah
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute /ID# 283512
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Virginia
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Richmond、Virginia、アメリカ、23298
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Hospitals and Clinics /ID# 282516
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Devon
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Plymouth、Devon、イギリス、PL6 8DH
- University Hospitals Plymouth NHS Trust /ID# 283108
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Edinburgh, City of
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Edinburgh、Edinburgh, City of、イギリス、EH4 2XU
- Western General Hospital - NHS Lothian /ID# 281838
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Greater London
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London、Greater London、イギリス、EC1A 7BE
- St Bartholomews Hospital - Barts Health /ID# 283714
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Hampshire
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Portsmouth、Hampshire、イギリス、PO6 3LY
- Queen Alexandra Hospital /ID# 281839
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North Lanarkshire
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Airdrie、North Lanarkshire、イギリス、ML6 0JS
- NHS Lanarkshire /ID# 282021
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Nottinghamshire
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Nottingham、Nottinghamshire、イギリス、NG5 1PB
- Nottingham City Hospital /ID# 282748
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Forlì-Cesena
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Meldola、Forlì-Cesena、イタリア、47014
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
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South Holland
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Leiden、South Holland、オランダ、2333 ZA
- Leids Universitair Medisch Centrum /ID# 283142
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Rotterdam、South Holland、オランダ、3015 CE
- Erasmus Medisch Centrum /ID# 283408
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New South Wales
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Wollongong、New South Wales、オーストラリア、2500
- Wollongong Hospital. /ID# 282694
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Queensland
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Benowa、Queensland、オーストラリア、4217
- Pindara Private Hospital /ID# 283010
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South Brisbane、Queensland、オーストラリア、4101
- Icon Cancer Care - South Brisbane /ID# 282965
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Victoria
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Melbourne、Victoria、オーストラリア、3000
- Peter MacCallum Cancer Centre. /ID# 282692
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Richmond、Victoria、オーストラリア、3121
- Epworth Hospital - Richmond /ID# 281877
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Western Australia
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Murdoch、Western Australia、オーストラリア、6150
- Fiona Stanley Hospital /ID# 281879
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Nedlands、Western Australia、オーストラリア、6009
- Sir Charles Gairdner Hospital /ID# 281881
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British Columbia
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Victoria、British Columbia、カナダ、V8R 6V5
- British Columbia Cancer Agency Vancouver Centre /ID# 282147
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Ontario
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London、Ontario、カナダ、N6A 5W9
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
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Quebec
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Montreal、Quebec、カナダ、H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
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Madrid、スペイン、28007
- Hospital General Universitario Gregorio Maranon /ID# 283342
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Cantabria
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Santander、Cantabria、スペイン、39008
- Hospital Universitario Marques de Valdecilla /ID# 283344
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Navarre
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Pamplona、Navarre、スペイン、31008
- Clinica Universidad de Navarra - Pamplona /ID# 283290
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Baden-Wurttemberg
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Freiburg im Breisgau、Baden-Wurttemberg、ドイツ、79106
- Universitaetsklinikum Freiburg /ID# 282874
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Karlsruhe、Baden-Wurttemberg、ドイツ、76133
- Staedtisches Klinikum Karlsruhe /ID# 283569
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Tübingen、Baden-Wurttemberg、ドイツ、72076
- Universitaetsklinikum Tuebingen /ID# 282873
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Ulm、Baden-Wurttemberg、ドイツ、89081
- Universitaetsklinikum Ulm /ID# 283884
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Bavaria
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Würzburg、Bavaria、ドイツ、97080
- Universitaetsklinikum Wuerzburg /ID# 283572
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Lower Saxony
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Hanover、Lower Saxony、ドイツ、30459
- Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
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North Rhine-Westphalia
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Bonn、North Rhine-Westphalia、ドイツ、53127
- Universitaetsklinikum Bonn /ID# 283881
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Cologne、North Rhine-Westphalia、ドイツ、50937
- Universitaetsklinikum Koeln /ID# 283930
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Sogn Og Fjordane
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Bergen、Sogn Og Fjordane、ノルウェー、5021
- Haukeland University Hospital /ID# 283524
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Vas County
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Szombathely、Vas County、ハンガリー、9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
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Alpes-Maritimes
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Nice、Alpes-Maritimes、フランス、06202
- Chu de Nice-Hopital Larchet Ii /Id# 283541
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Indre-et-Loire
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Tours、Indre-et-Loire、フランス、37044
- CHRU Tours - Hopital Bretonneau /ID# 281925
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy、Meurthe-et-Moselle、フランス、54511
- Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
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Pays de la Loire Region
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Nantes、Pays de la Loire Region、フランス、44000
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
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Provence-Alpes-Côte d'Azur Region
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Avignon、Provence-Alpes-Côte d'Azur Region、フランス、84000
- Centre Hospitalier d'Avignon /ID# 283509
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Braga、ポルトガル、4710-243
- 2CA-Braga, Hospital de Braga /ID# 283828
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Porto、ポルトガル、4200-319
- Unidade Local de Saude Sao Joao /ID# 283530
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Lisbon District
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Lisbon、Lisbon District、ポルトガル、1449-005
- Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
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Porto District
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Vila Nova de Gaia、Porto District、ポルトガル、4434-502
- Unidade Local de Saude de Gaia/Espinho /ID# 283492
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Kaohsiung City、台湾、833
- Kaohsiung Chang Gung Memorial Hospital /ID# 282970
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Safety Run-In: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
|
Injection
Oral
|
|
実験的：Randomized Portion: Etentamig Plus Pomalidomide
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
|
Injection
Oral
|
|
アクティブコンパレータ：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.
|
注入
注入
Oral or Injection
Injection
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Run-In: Number of Participants With Adverse Events (AE)s
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
時間枠：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
時間枠：Up to Approximately 12 Months
|
Cmax of Etentamig.
|
Up to Approximately 12 Months
|
|
Safety Run-In: Time to Cmax (Tmax) of Etentamig
時間枠：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
時間枠：Up to Approximately 12 Months
|
Cmax of Etentamig.
|
Up to Approximately 12 Months
|
|
Safety Run-In: Immunogenicity of Etentamig
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：ABBVIE INC.、AbbVie
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月30日
一次修了 (推定)
2033年2月1日
研究の完了 (推定)
2033年2月1日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
2026年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- M22-538
- 2026-525596-11-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 共有アクセス基準
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。