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보르테조밉, 레날리도마이드 및 덱사메타손(VRd) 이후 Cilta-cel, BCMA에 대한 CAR-T 요법 대 VRd 이후 레날리도마이드 및 덱사메타손(Rd) 요법에 대한 연구 초기 치료 (CARTITUDE-5)

2026년 11월 2일 업데이트: Janssen Research & Development, LLC

보르테조밉, 레날리도마이드 및 덱사메타손(VRd) 이후에 Ciltacabtagene Autoleucel, BCMA에 대한 키메라 항원 수용체 T 세포(CAR-T) 요법과 보르테조밉, 레날리도마이드 및 덱사메타손(VRd) 이후 레날리도마이드 및 덱사메타손을 비교하는 3상 무작위 연구( Rd) 초기 치료로 조혈모세포 이식이 계획되지 않은 새로 진단된 다발성 골수종 환자의 치료

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).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

743

단계

  • 3단계

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연구 장소

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

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

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: 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.
의약품: Bortezomib

Bortezomib will be administered SC.

의약품: Dexamethasone

Dexamethasone will be administered orally.

의약품: Lenalidomide

Lenalidomide will be administered orally.
실험적: 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).
의약품: Bortezomib

Bortezomib will be administered SC.

의약품: Dexamethasone

Dexamethasone will be administered orally.

의약품: Lenalidomide

Lenalidomide will be administered orally.

의약품: Cilta-cel

Cilta-cel infusion will be administered.

다른 이름들:
  • JNJ-68284528
의약품: Cyclophosphamide

Cyclophosphamide will be administered intravenously.

의약품: Fludarabine

Fludarabine will be administered intravenously.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Sustained Minimal Residual Disease (MRD) Negative CR
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

수사관

  • 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

간행물 및 유용한 링크

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유용한 링크

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 (실제)

2021년 8월 19일

기본 완료 (추정된)

2029년 2월 14일

연구 완료 (추정된)

2036년 9월 22일

연구 등록 날짜

최초 제출

2021년 6월 10일

QC 기준을 충족하는 최초 제출

2021년 6월 10일

처음 게시됨 (실제)

2021년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CR109015
  • 2021-001242-35 (EudraCT 번호)
  • 68284528MMY3004 (기타 식별자: Janssen Research & Development, LLC)
  • 2023-505850-16-00 (레지스트리 식별자: EUCT number)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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