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Uno studio su bortezomib, lenalidomide e desametasone (VRd) seguiti da Cilta-cel, una terapia CAR-T diretta contro BCMA rispetto a VRd seguita da terapia con lenalidomide e desametasone (Rd) in partecipanti con mieloma multiplo di nuova diagnosi per i quali ASCT non è pianificato come Terapia iniziale (CARTITUDE-5)

2 novembre 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio randomizzato di fase 3 che confronta bortezomib, lenalidomide e desametasone (VRd) seguiti da ciltacabtagene autoleucel, una terapia con cellule T del recettore dell'antigene chimerico (CAR-T) diretta contro BCMA rispetto a bortezomib, lenalidomide e desametasone (VRd) seguiti da lenalidomide e desametasone ( Rd) Terapia nei partecipanti con mieloma multiplo di nuova diagnosi per i quali il trapianto di cellule staminali ematopoietiche non è pianificato come terapia iniziale

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).

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

743

Fase

  • Fase 3

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Bortezomib

Bortezomib will be administered SC.

Droga: Dexamethasone

Dexamethasone will be administered orally.

Droga: Lenalidomide

Lenalidomide will be administered orally.
Sperimentale: 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).
Droga: Bortezomib

Bortezomib will be administered SC.

Droga: Dexamethasone

Dexamethasone will be administered orally.

Droga: Lenalidomide

Lenalidomide will be administered orally.

Droga: Cilta-cel

Cilta-cel infusion will be administered.

Altri nomi:
  • JNJ-68284528
Droga: Cyclophosphamide

Cyclophosphamide will be administered intravenously.

Droga: Fludarabine

Fludarabine will be administered intravenously.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sustained Minimal Residual Disease (MRD) Negative CR
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 agosto 2021

Completamento primario (Stimato)

14 febbraio 2029

Completamento dello studio (Stimato)

22 settembre 2036

Date di iscrizione allo studio

Primo inviato

10 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2021

Primo Inserito (Effettivo)

11 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR109015
  • 2021-001242-35 (Numero EudraCT)
  • 68284528MMY3004 (Altro identificatore: Janssen Research & Development, LLC)
  • 2023-505850-16-00 (Identificatore di registro: EUCT number)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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