Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Badanie bortezomibu, lenalidomidu i deksametazonu (VRd), a następnie Cilta-cel, terapii CAR-T skierowanej przeciwko BCMA w porównaniu z VRd, a następnie lenalidomidem i deksametazonem (Rd) u uczestników z nowo zdiagnozowanym szpiczakiem mnogim, u których nie planuje się ASCT jako Terapia wstępna (CARTITUDE-5)

2 listopada 2026 zaktualizowane przez: Janssen Research & Development, LLC

Randomizowane badanie fazy 3 porównujące bortezomib, lenalidomid i deksametazon (VRd), a następnie ciltacabtagene Autoleucel, terapię chimerycznym receptorem antygenu limfocytów T (CAR-T) skierowaną przeciwko BCMA w porównaniu z bortezomibem, lenalidomidem i deksametazonem (VRd), a następnie lenalidomidem i deksametazonem ( Rd) Terapia uczestników z nowo rozpoznanym szpiczakiem mnogim, u których przeszczep hematopoetycznych komórek macierzystych nie jest planowany jako terapia początkowa

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).

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

743

Faza

  • Faza 3

Rozszerzony dostęp

Do dyspozycji poza badaniem klinicznym. Zobacz rozwinięty rekord dostępu.

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Bortezomib

Bortezomib will be administered SC.

Lek: Dexamethasone

Dexamethasone will be administered orally.

Lek: Lenalidomide

Lenalidomide will be administered orally.
Eksperymentalny: 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).
Lek: Bortezomib

Bortezomib will be administered SC.

Lek: Dexamethasone

Dexamethasone will be administered orally.

Lek: Lenalidomide

Lenalidomide will be administered orally.

Lek: Cilta-cel

Cilta-cel infusion will be administered.

Inne nazwy:
  • JNJ-68284528
Lek: Cyclophosphamide

Cyclophosphamide will be administered intravenously.

Lek: Fludarabine

Fludarabine will be administered intravenously.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival (PFS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sustained Minimal Residual Disease (MRD) Negative CR
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 sierpnia 2021

Zakończenie podstawowe (Szacowany)

14 lutego 2029

Ukończenie studiów (Szacowany)

22 września 2036

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CR109015
  • 2021-001242-35 (Numer EudraCT)
  • 68284528MMY3004 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2023-505850-16-00 (Identyfikator rejestru: EUCT number)
  • 2023 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj