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ボルテゾミブ、レナリドマイドおよびデキサメタゾン（VRd）に続いて Cilta-cel、BCMA 対 VRd に対する CAR-T 療法、その後にレナリドマイドおよびデキサメタゾン（Rd）療法が続く、ASCT が予定されていない新たに多発性骨髄腫と診断された参加者の研究初期治療 (CARTITUDE-5)

2026年11月2日 更新者：Janssen Research & Development, LLC

ボルテゾミブ、レナリドマイドおよびデキサメタゾン (VRd) に続いて、BCMA に対するキメラ抗原受容体 T 細胞 (CAR-T) 療法である Ciltacabtagene Autoleucel と、ボルテゾミブ、レナリドミドおよびデキサメタゾン (VRd) に続いてレナリドマイドおよびデキサメタゾンを比較する第 3 相ランダム化試験 ( Rd) 造血幹細胞移植が初期治療として計画されていない、新たに多発性骨髄腫と診断された参加者の治療

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.

研究の種類

介入

入学 (実際)

743

段階

  • フェーズ 3

アクセスの拡大

利用可能 臨床試験外。 拡張アクセス記録をご覧ください。

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。

研究場所

  • アイルランド
      • Dublin、アイルランド、D08 NHY1
        • St James Hospital
  • アメリカ
    • California
      • San Francisco、California、アメリカ、94143
        • UCSF
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale Cancer Center
    • Florida
      • Miami、Florida、アメリカ、33136
        • University of Miami Health System
      • Orlando、Florida、アメリカ、32832
        • AdventHealth Cancer Institute
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536-0293
        • University of Kentucky
      • Louisville、Kentucky、アメリカ、40207
        • Norton Cancer Institute
    • Maryland
      • Baltimore、Maryland、アメリカ、21201-1595
        • University Of Maryland Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit、Michigan、アメリカ、48202-2608
        • Henry Ford Cancer Institute
    • New York
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center
      • New York、New York、アメリカ、10065
        • Memorial Sloan-Kettering Cancer Center
      • New York、New York、アメリカ、10065
        • New York Presbyterian-Weill Cornell Medical College
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Levine Cancer Institute
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Thomas Jefferson University
      • Pittsburgh、Pennsylvania、アメリカ、15232
        • University of Pittsburgh Medical Center
    • Virginia
      • Charlottesville、Virginia、アメリカ、22903
        • University of Virginia
    • Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53226
        • Medical College Of Wisconsin
  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1118AAT
        • Hospital Aleman
      • Buenos Aires、アルゼンチン、C1199ABD
        • Hospital Italiano de Buenos Aires
      • Córdoba、アルゼンチン、5016
        • Hospital Privado Universitario De Cordoba
  • イギリス
      • Birmingham、イギリス、B15 2TH
        • University Hospitals Birmingham NHS Trust,
      • Bristol、イギリス、BS2 8BJ
        • Bristol Royal Infirmary
      • Leeds、イギリス、LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • London、イギリス、SE5 9RS
        • Kings College Hospital
      • London、イギリス、NW1 2BU
        • University College Hospital
      • Manchester、イギリス、M13 9WL
        • Manchester Royal Infirmary
      • Surrey、イギリス、SM2 5PT
        • The Royal Marsden NHS Trust Sutton
  • イスラエル
      • Jerusalem、イスラエル、P.O.B. 120
        • Hadassah University Hospita Ein Kerem
      • Ramat Gan、イスラエル、52621
        • Sheba Medical Center Tel Hashomer
      • Tel Aviv、イスラエル、64239
        • Tel Aviv Sourasky Medical Center
  • オランダ
      • Amsterdam、オランダ、1081 HV
        • VU Medisch Centrum
      • Groningen、オランダ、9713 GZ
        • University Medical Center Groningen
      • Nijmegen、オランダ、6500 HB
        • UMC Radboud
      • Rotterdam、オランダ、3075 EA
        • Erasmus MC
  • オーストラリア
      • Camperdown、オーストラリア、2050
        • Royal Prince Alfred Hospital
      • Fitzroy、オーストラリア、3065
        • St Vincents Hospital Melbourne
      • Heidelberg、オーストラリア、3084
        • Austin Health
      • Herston、オーストラリア、4029
        • Royal Brisbane and Womens Hospital
      • Melbourne、オーストラリア、3004
        • Alfred Health
      • Melbourne、オーストラリア、8006
        • Peter MacCallum Cancer Centre
      • Murdoch、オーストラリア、6150
        • Fiona Stanley Hospital
      • Waratah、オーストラリア、2298
        • Calvary Mater Newcastle Hospital
      • Westmead、オーストラリア、2145
        • Western Sydney Local Health District
  • オーストリア
      • Graz、オーストリア、8036
        • Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
      • Linz、オーストリア、4020
        • Krankenhaus der Elisabethinen Linz
      • Salzburg、オーストリア、5020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Vienna、オーストリア、1090
        • Medical University of Vienna Universitatsklinik fur Innere Medizin I
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Hamilton、Ontario、カナダ、L8V5C2
        • Juravinski Cancer Centre
      • Toronto、Ontario、カナダ、M5G2M9
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal、Quebec、カナダ、H1T 2M4
        • Hopital Maisonneuve Rosemont
  • ギリシャ
      • Athens、ギリシャ、11528
        • Alexandra General Hospital of Athens
      • Athens、ギリシャ、12462
        • Attikon University General Hospital of Attica
      • Thessaloniki、ギリシャ、57010
        • G.Papanikolaou
  • スイス
      • Basel、スイス、4031
        • Universitatsspital Basel
      • Bern、スイス、3010
        • Inselspital Universitatsspital Bern
      • Sankt Gallen、スイス、9007
        • Kantonsspital St Gallen
  • スウェーデン
      • Gothenburg、スウェーデン、413 45
        • Sahlgrenska University Hospital
      • Linköping、スウェーデン、58185
        • Universitetssjukhuset
      • Lund、スウェーデン、221 85
        • Skane University Hospital
  • スペイン
      • Barcelona、スペイン、08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona、スペイン、8035
        • Hosp Univ Vall D Hebron
      • L'Hospitalet de Llobregat、スペイン、08908
        • Instituto Catalan Deoncologia Hospital Duran I Reynals
      • Madrid、スペイン、28041
        • Hosp. Univ. 12 de Octubre
      • Madrid、スペイン、28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Murcia、スペイン、30120
        • Hosp. Univ. Virgen de La Arrixaca
      • Pamplona、スペイン、31008
        • Clinica Univ. de Navarra
      • Salamanca、スペイン、37007
        • Hosp Clinico Univ de Salamanca
      • Santander、スペイン、39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville、スペイン、41013
        • Hosp. Virgen Del Rocio
      • Valencia、スペイン、46026
        • Hosp. Univ. I Politecni La Fe
  • チェコ
      • Brno、チェコ、625 00
        • Fakultni nemocnice Brno
      • Hradec Králové、チェコ、500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava - Poruba、チェコ、708 52
        • Fakultni Nemocnice Ostrava
      • Prague、チェコ、128 08
        • Vseobecna fakultni nemocnice v Praze
  • デンマーク
      • Aarhus N、デンマーク、8200
        • Aarhus University Hospital
      • Copenhagen、デンマーク、2100
        • Rigshospitalet
      • Odense C、デンマーク、5000
        • Odense Universitetshospital
  • ドイツ
      • Berlin、ドイツ、12203
        • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
      • Dresden、ドイツ、01307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Freiburg im Breisgau、ドイツ、79106
        • Universitatsklinikum Freiburg
      • Hamburg、ドイツ、20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Heidelberg、ドイツ、69120
        • Universitaetsklinikum Heidelberg
      • Leipzig、ドイツ、04103
        • Universitaetsklinikum Leipzig
      • Mainz、ドイツ、55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • München、ドイツ、81377
        • Klinikum Grosshadern Der Ludwig-Maximilians-Universitat
      • Regensburg、ドイツ、93053
        • Universitaetsklinikum Regensburg
      • Tübingen、ドイツ、72076
        • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
      • Würzburg、ドイツ、97080
        • Universitatsklinikum Wurzburg
  • ノルウェー
      • Oslo、ノルウェー、0372
        • Oslo universitetssykehus HF, Rikshospitalet
  • ハンガリー
      • Budapest、ハンガリー、1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
      • Debrecen、ハンガリー、4032
        • Debreceni Egyetem Klinikai Kozpont
  • フィンランド
      • Helsinki、フィンランド、00290
        • Helsinki University Hospital
      • Oulu、フィンランド、90220
        • Oulu University Hospital
      • Turku、フィンランド、20520
        • Turku University Hospital
  • フランス
      • Lille、フランス、59000
        • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
      • Nantes、フランス、44093
        • C.H.U. Hotel Dieu - France
      • Paris、フランス、75475
        • Hopital Saint Louis
      • Poitiers、フランス、86021
        • CHU Poitiers - Hopital la Miletrie
      • Toulouse、フランス、31059
        • Institut Universitaire du cancer de Toulouse-Oncopole
  • ブラジル
      • Salvador、ブラジル、41253-190
        • IDOR - Regional Bahia
      • São Paulo、ブラジル、01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo、ブラジル、05651-901
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • ベルギー
      • Antwerp、ベルギー、2650
        • Universitair Ziekenhuis - Antwerpen
      • Bruges、ベルギー、8000
        • AZ St.-Jan Brugge-Oostende AV
      • Ghent、ベルギー、9000
        • UZ Gent
      • Leuven、ベルギー、3000
        • UZ Leuven
      • Liège、ベルギー、B-4000
        • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • ポルトガル
      • Lisbon、ポルトガル、1099-023
        • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. 1
      • Porto、ポルトガル、4200072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
  • ポーランド
      • Gdansk、ポーランド、80 214
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice、ポーランド、44102
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
      • Lublin、ポーランド、20 090
        • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
      • Poznan、ポーランド、60 569
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw、ポーランド、02 776
        • Instytut Hematologii i Transfuzjologii
      • Wroclaw、ポーランド、50 367
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • 日本
      • Bunkyō City、日本、113 8431
        • Juntendo University Hospital
      • Fukuoka、日本、812 8582
        • Kyushu University Hospital
      • Hyôgo、日本、663-8501
        • Hyogo Medical University Hospital
      • Kanazawa、日本、920 8641
        • Kanazawa University Hospital
      • Kyoto、日本、602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Nagoya、日本、467 8602
        • Nagoya City University Hospital
      • Okayama、日本、700 8558
        • Okayama University Hospital
      • Sapporo、日本、060-8648
        • Hokkaido University Hospital
      • Sendai、日本、980 8574
        • Tohoku University Hospital
      • Shibuya City、日本、150-8935
        • Japanese Red Cross Medical Center
  • 韓国
      • Jeollanam-do、韓国、58128
        • Chonnam National University Hwasun Hospital
      • Seoul、韓国、03080
        • Seoul National University Hospital
      • Seoul、韓国、05505
        • Asan Medical Center
      • Seoul、韓国、03722
        • Severance Hospital Yonsei University Health System
      • Seoul、韓国、06351
        • Samsung Medical Center
      • Seoul、韓国、06591
        • The Catholic University of Korea Seoul St Marys Hospital

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
  • Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
  • A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
  • Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)

Exclusion Criteria:

  • Frailty index of >=2 according to Myeloma Geriatric Assessment score
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
  • Seropositive for human immunodeficiency virus (HIV)
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
  • Participant must not require continuous supplemental oxygen
  • Hepatitis B infection
  • Hepatitis C infection
  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Any therapy that is targeted to B-cell maturation antigen (BCMA)

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：Arm A: VRd+Rd (Standard Therapy)

Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
薬：Bortezomib

Bortezomib will be administered SC.

薬：Dexamethasone

Dexamethasone will be administered orally.

薬：Lenalidomide

Lenalidomide will be administered orally.
実験的：Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)

Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).
薬：Bortezomib

Bortezomib will be administered SC.

薬：Dexamethasone

Dexamethasone will be administered orally.

薬：Lenalidomide

Lenalidomide will be administered orally.

薬：Cilta-cel

Cilta-cel infusion will be administered.

他の名前：
  • JNJ-68284528
薬：Cyclophosphamide

Cyclophosphamide will be administered intravenously.

薬：Fludarabine

Fludarabine will be administered intravenously.

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
Progression Free Survival (PFS)
時間枠：Up to 4 years and 5 months

Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Up to 4 years and 5 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Sustained Minimal Residual Disease (MRD) Negative CR
時間枠：Up to 12 years and 5 months

Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status.
Up to 12 years and 5 months
MRD Negative CR at 9 Months
時間枠：9 months

MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.
9 months
Overall MRD Negative CR
時間枠：Up to 12 years and 5 months

Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy.
Up to 12 years and 5 months
Overall Survival (OS)
時間枠：Up to 12 years and 5 months

Overall survival is measured from the date of randomization to the date of the participant's death.
Up to 12 years and 5 months
Complete Response or Better
時間枠：Up to 12 years and 5 months

CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
Up to 12 years and 5 months
Time to Subsequent Anti-myeloma Therapy
時間枠：Up to 12 years and 5 months

Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
Up to 12 years and 5 months
Progression Free Survival on Next-line Therapy (PFS2)
時間枠：Up to 12 years and 5 months

PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.
Up to 12 years and 5 months
Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs
時間枠：Up to 12 years and 5 months

Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported.
Up to 12 years and 5 months
Arm B: Systemic Cytokine Concentrations
時間枠：Up to Day 112

Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.
Up to Day 112
Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
時間枠：Up to 12 years and 5 months

CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response.
Up to 12 years and 5 months
Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
時間枠：Up to 1 year

Levels of soluble BCMA will be reported.
Up to 1 year
Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
時間枠：Up to 12 years and 5 months

Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Up to 12 years and 5 months
Arm B: Number of Participants with Anti-cilta-cel Antibodies
時間枠：Up to 12 years and 5 months

Number of participants with anti-cilta-cel antibodies will be reported.
Up to 12 years and 5 months
Arm B: Number of Participants with Presence of Replication Competent Lentivirus
時間枠：Up to 12 years and 5 months

Number of participants with presence of replication competent lentivirus will be reported.
Up to 12 years and 5 months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
時間枠：Baseline up to 12 years and 5 months

The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Baseline up to 12 years and 5 months
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
時間枠：Baseline up to 12 years and 5 months

The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Baseline up to 12 years and 5 months
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
時間枠：Baseline up to 12 years and 5 months

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline up to 12 years and 5 months
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
時間枠：Baseline up to 12 years and 5 months

The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Baseline up to 12 years and 5 months
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
時間枠：Up to 161 days

The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Up to 161 days
Time to Worsening of Symptoms, Functioning and Overall Well-being
時間枠：Up to 12 year and 5 months

Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores.
Up to 12 year and 5 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

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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 (実際)

2021年8月19日

一次修了 (推定)

2029年2月14日

研究の完了 (推定)

2036年9月22日

試験登録日

最初に提出

2021年6月10日

QC基準を満たした最初の提出物

2021年6月10日

最初の投稿 (実際)

2021年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11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

  • CR109015
  • 2021-001242-35 (EudraCT番号)
  • 68284528MMY3004 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-505850-16-00 (レジストリ識別子：EUCT number)
  • 2023 (米国 NIH グラント/契約)

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

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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

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。

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