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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

743

Participants

Timeline

Start Date

August 19, 2021

Primary Completion Date

February 14, 2029

Study Completion Date

September 22, 2036

Conditions
Multiple Myeloma
Interventions
DRUG

Bortezomib

Bortezomib will be administered SC.

DRUG

Dexamethasone

Dexamethasone will be administered orally.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Cilta-cel

Cilta-cel infusion will be administered.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUG

Fludarabine

Fludarabine will be administered intravenously.

Trial Locations (136)

1090

Medical University of Vienna Universitatsklinik fur Innere Medizin I, Vienna

1097

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely, Budapest

2050

Royal Prince Alfred Hospital, Camperdown

2100

Rigshospitalet, Copenhagen

2145

Western Sydney Local Health District, Westmead

2298

Calvary Mater Newcastle Hospital, Waratah

2650

Universitair Ziekenhuis - Antwerpen, Antwerp

3000

UZ Leuven, Leuven

3004

Alfred Health, Melbourne

3010

Inselspital Universitatsspital Bern, Bern

3065

St Vincents Hospital Melbourne, Fitzroy

3084

Austin Health, Heidelberg

4020

Krankenhaus der Elisabethinen Linz, Linz

4029

Royal Brisbane and Womens Hospital, Herston

4031

Universitatsspital Basel, Basel

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5000

Odense Universitetshospital, Odense C

5016

Hospital Privado Universitario De Cordoba, Córdoba

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

6150

Fiona Stanley Hospital, Murdoch

8000

AZ St.-Jan Brugge-Oostende AV, Bruges

Aarhus University Hospital, Aarhus C

8006

Peter MacCallum Cancer Centre, Melbourne

8035

Hosp Univ Vall D Hebron, Barcelona

8036

Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie, Graz

9000

UZ Gent, Ghent

9007

Kantonsspital St Gallen, Sankt Gallen

10032

Columbia University Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

New York Presbyterian-Weill Cornell Medical College, New York

11528

Alexandra General Hospital of Athens, Athens

12203

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin

12462

Attikon University General Hospital of Attica, Athens

15232

University of Pittsburgh Medical Center, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

20246

Universitaetsklinikum Hamburg Eppendorf, Hamburg

20520

Turku University Hospital, Turku

22903

University of Virginia, Charlottesville

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

30120

Hosp. Univ. Virgen de La Arrixaca, Murcia

31008

Clinica Univ. de Navarra, Pamplona

31059

Institut Universitaire du cancer de Toulouse-Oncopole, Toulouse

32832

AdventHealth Cancer Institute, Orlando

33136

University of Miami Health System, Miami

37007

Hosp Clinico Univ de Salamanca, Salamanca

39008

Hosp. Univ. Marques de Valdecilla, Santander

40207

Norton Cancer Institute, Louisville

41013

Hosp. Virgen Del Rocio, Seville

44093

C.H.U. Hotel Dieu - France, Nantes

44102

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach, Gliwice

46026

Hosp. Univ. I Politecni La Fe, Valencia

48201

Barbara Ann Karmanos Cancer Institute, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

52621

Sheba Medical Center Tel Hashomer, Ramat Gan

53226

Medical College Of Wisconsin, Milwaukee

55131

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz

57010

G.Papanikolaou, Thessaloniki

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

58185

Universitetssjukhuset, Linköping

59000

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69120

Universitaetsklinikum Heidelberg, Heidelberg

72076

Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany, Tübingen

75475

Hopital Saint Louis, Paris

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

81377

Klinikum Großhadern der Ludwig-Maximilians-Universität, München

86021

CHU Poitiers - Hopital la Miletrie, Poitiers

90220

Oulu University Hospital, Oulu

93053

Universitaetsklinikum Regensburg, Regensburg

94143

UCSF, San Francisco

97080

Universitatsklinikum Wurzburg, Würzburg

4200072

Instituto Portugues de Oncologia, Porto

06510

Yale Cancer Center, New Haven

40536-0293

University of Kentucky, Lexington

21201-1595

University Of Maryland Medical Center, Baltimore

02215

Beth Israel Deaconess Medical Center, Boston

48202-2608

Henry Ford Cancer Institute, Detroit

C1118AAT

Hospital Aleman, Buenos Aires

C1199ABD

Hospital Italiano de Buenos Aires, Buenos Aires

B-4000

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Liège

41253-190

Hospital Sao Rafael, Salvador

01509 900

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

05652 900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

T2N 5G2

Arthur J E Child Comprehensive Cancer Centre, Calgary

V5Z 1M9

Vancouver General Hospital, Vancouver

L8V5C2

Juravinski Cancer Centre, Hamilton

M5G2M9

Princess Margaret Cancer Centre University Health Network, Toronto

H1T 2M4

Hopital Maisonneuve Rosemont, Montreal

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni Nemocnice Ostrava, Ostrava - Poruba

128 08

Vseobecna fakultni nemocnice v Praze, Prague

00029 HUS

Helsinki University Hospital, Helsinki

01307

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

04103

Universitaetsklinikum Leipzig, Leipzig

D08 NHY1

St James Hospital, Dublin

P.O.B. 12000

Hadassah University Hospita Ein Kerem, Jerusalem

113 8431

Juntendo University Hospital, Bunkyō City

812 8582

Kyushu University Hospital, Fukuoka

663-8501

Hyogo Medical University Hospital, Hyôgo

920 8641

Kanazawa University Hospital, Kanazawa

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

467 8602

Nagoya City University Hospital, Nagoya

700 8558

Okayama University Hospital, Okayama

060-8648

Hokkaido University Hospital, Sapporo

980 8574

Tohoku University Hospital, Sendai

150-8935

Japanese Red Cross Medical Center, Shibuya City

1081 HV

VU Medisch Centrum, Amsterdam

9713 GZ

University Medical Center Groningen, Groningen

6500 HB

UMC Radboud, Nijmegen

3075 EA

Erasmus MC, Rotterdam

0372

Oslo universitetssykehus HF, Rikshospitalet, Oslo

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

20 090

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli, Lublin

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

02 776

Instytut Hematologii i Transfuzjologii, Warsaw

50 367

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

1099-023

Instituto Portugues de Oncologia, Lisbon

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08908

Instituto Catalan Deoncologia Hospital Duran I Reynals, L'Hospitalet de Llobregat

413 45

Sahlgrenska University Hospital, Gothenburg

221 85

Skane University Hospital, Lund

B15 2TH

University Hospitals Birmingham NHS Trust,, Birmingham

BS2 8BJ

Bristol Royal Infirmary, Bristol

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

NW1 2BU

University College Hospital, London

SE5 9RS

Kings College Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

SM2 5PT

The Royal Marsden NHS Trust Sutton, Surrey

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY