Multiple Myeloma Clinical Trial

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

Summary

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).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04923893

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 145 Locations for this study

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UCSF
San Francisco California, 94143, United States
Stanford University Medical Center
Stanford California, 94305, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
University of Miami Health System
Miami Florida, 33136, United States
AdventHealth Cancer Institute
Orlando Florida, 32832, United States
Loyola University Medical Center
Melrose Park Illinois, 60160, United States
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States
University of Kansas Medical Center
Westwood Kansas, 66205, United States
University of Kentucky
Lexington Kentucky, 40536, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
University Of Maryland Medical Center
Baltimore Maryland, 21201, United States
Harvard Medical School-Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Massachusetts General Hospital
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Cancer Institute
Detroit Michigan, 48202, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
New York Presbyterian-Weill Cornell Medical College
New York New York, 10065, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Hospital Aleman
Buenos Aires , C1118, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires , C1199, Argentina
Hospital Privado Centro Medico de Cordoba
Cordoba , X5016, Argentina
Hospital Universitario Austral
Pilar , 1629, Argentina
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Austin Health
Heidelberg , 3084, Australia
Royal Brisbane and Womens Hospital
Herston , 4029, Australia
Alfred Health
Melbourne , 3004, Australia
Peter MacCallum Cancer Centre
Melbourne , 8006, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Calvary Mater Newcastle Hospital
Waratah , 2298, Australia
Western Sydney Local Health District
Westmead , 2145, Australia
Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
Graz , 8036, Austria
Medizinische Universitatsklinik Innsbruck
Innsbruck , 6020, Austria
Krankenhaus der Elisabethinen Linz
Linz , 4020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg , 5020, Austria
Medical University of Vienna,Universitätsklinik für Innere Medizin I
Vienna , 1090, Austria
Universitair Ziekenhuis - Antwerpen
Antwerp , 2650, Belgium
AZ St.-Jan Brugge-Oostende AV
Brugge , 8000, Belgium
Cliniques Universitaires St-Luc
Brussel , 1200, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege , B-400, Belgium
Hospital Sao Rafael
Salvador , 41253, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo , 05652, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada
Princess Margaret Cancer Centre University Health Network
Toronto Ontario, M5G2M, Canada
Hopital Maisonneuve-Rosemont
Montréal Quebec, H1T 2, Canada
Vancouver General Hospital
Vancouver , V5Z 1, Canada
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
Fakultni nemocnice Plzen
Plzen-Lochotin , 304 6, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Aarhus University Hospital
Aarhus C , 8000, Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Odense Universitetshospital
Odense C , 5000, Denmark
Helsinki University Hospital
Helsinki , 00029, Finland
Oulu University Hospital
Oulu , 90220, Finland
Turku University Hospital
Turku , 20520, Finland
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille Cedex , 59000, France
C.H.U. Hotel Dieu - France
Nantes , 44093, France
Hopital Saint-Louis
Paris cedex 10 , 75475, France
CHU Poitiers - Hôpital la Milétrie
Poitiers , 86021, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse cedex 9 , 31059, France
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin , 12203, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden , 01307, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
Universitaetsklinikum Regensburg
Regensburg , 93053, Germany
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Tübingen , 72076, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Attikon University General Hospital of Attica
Athens , 12462, Greece
G.Papanikolaou
Thessaloniki , 57010, Greece
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
St James's Hospital
Dublin , D08 N, Ireland
Hadassah University Hospita - Ein Kerem
Jerusalem , P.O.B, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Kyushu University Hospital
Fukuoka , 812-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
University Hospital Kyoto Perfectural University of Medicine
Kyoto , 602-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Hokkaido University Hospital
Sapporo , 060-8, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
University Medical Center Groningen
Groningen , 9713 , Netherlands
UMC Radboud
Nijmegen , 6500 , Netherlands
Erasmus MC
Rotterdam , 3075 , Netherlands
Oslo universitetssykehus HF, Rikshospitalet
Oslo , 0372, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Gliwice , 44102, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20-09, Poland
Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Poznań , 60-56, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
Instituto Portugues de Oncologia
Lisboa , 1099-, Portugal
Hospital De Santa Maria
Lisboa , 1649-, Portugal
Instituto Portugues de Oncologia
Porto , 42000, Portugal
Hosp. de La Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Instituto Catalan Deoncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat , 08908, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. Virgen de La Arrixaca
Murcia , 30120, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
Sahlgrenska University Hospital
Göteborg , 413 4, Sweden
Universitetssjukhuset
Linköping , 58185, Sweden
Skane University Hospital
Lund , 221 8, Sweden
Haematology Centre, R 51
Stockholm , SE-14, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Universitatsspital Basel
Basel , 4031, Switzerland
Ente Ospedaliero Cantonale
Bellinzona , 6500, Switzerland
INSELSPITAL, Universitätsspital Bern
Bern , 3010, Switzerland
Hôpitaux Universitaires de Genève - HUG
Genève , 1205, Switzerland
Kantonsspital St.Gallen
St. Gallen , 9007, Switzerland
UniversitaetsSpital Zuerich
Zürich , , Switzerland
University Hospitals Birmingham NHS Trust,
Birmingham , B15 2, United Kingdom
Bristol Royal Infirmary
Bristol , BS2 8, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , LS9 7, United Kingdom
University College Hospital
London , NW1 2, United Kingdom
King's College Hospital
London , SE5 9, United Kingdom
Manchester Royal Infirmary
Manchester , M13 9, United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04923893

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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