A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

June 12, 2020

Primary Completion Date

May 1, 2024

Study Completion Date

September 22, 2036

Conditions
Multiple Myeloma
Interventions
DRUG

Cilta-cel

Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).

DRUG

Pomalidomide

Pomalidomide 4 mg will be administered orally.

DRUG

Bortezomib

Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).

DRUG

Dexamethasone

Dexamethasone 20 mg/day (10mg/day for participants \>75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants \>75 years of age) in DPd treatment.

DRUG

Daratumumab

Daratumumab 1800 mg will be administered SC.

Trial Locations (88)

2050

Royal Prince Alfred Hospital, Camperdown

2100

Rigshospitalet, Copenhagen

2650

Universitair Ziekenhuis - Antwerpen, Antwerp

3000

Peter MacCallum Cancer Centre, Melbourne

UZ Leuven, Leuven

3004

Alfred Health, Melbourne

4029

Royal Brisbane and Womens Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

6150

Fiona Stanley Hospital, Murdoch

9000

UZ Gent, Ghent

10065

Memorial Sloan-Kettering Cancer Center, New York

10126

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin

12462

Attikon University General Hospital of Attica, Athens

14642

University of Rochester Medical Center, Rochester

20132

IRCCS Ospedale San Raffaele HSR, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20246

Universitaetsklinikum Hamburg Eppendorf, Hamburg

21201

University Of Maryland Medical Center, Baltimore

27710

Duke University Medical Center, Durham

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

31008

Clinica Univ. de Navarra, Pamplona

31059

Institut Universitaire du cancer de Toulouse-Oncopole, Toulouse

33136

University Of Miami Leonard M Mille School Of Medicine SCCC, Miami

34295

CHU de Montpellier Hopital Saint Eloi, Montpellier

35294

University of Alabama at Birmingham, Birmingham

37007

Hosp Clinico Univ de Salamanca, Salamanca

40138

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna

41013

Hosp. Virgen Del Rocio, Seville

43210

The Ohio State University, Columbus

44093

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

44102

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

50924

Universitaetsklinikum Koeln, Cologne

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Medical College Of Wisconsin, Milwaukee

53705

Wisconsin Institutes for Medical Research, Madison

55905

Mayo Clinic - Rochester, Rochester

59037

CHRU de Lille Hopital Claude Huriez, Lille

63110

Washington University School Of Medicine, St Louis

64239

Sourasky Medical Center, Tel Aviv

66205

University of Kansas, Westwood

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

72076

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

74047

Sheba Medical Center, Ramat Gan

75475

Hopital Saint Louis, Paris

80218

Colorado Blood Cancer Institute, Denver

84112

Huntsman Cancer Institute, Salt Lake City

85054

Mayo Clinic Cancer Center-Scottsdale, Phoenix

86021

CHU De Poitiers, Poitiers

97080

Universitatsklinikum Wurzburg, Würzburg

94305-5623

Stanford University Medical Center, Stanford

06520

Yale New Haven Hospital, New Haven

07601

Hackensack University Medical Center, Hackensack

B-4000

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

01307

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden, Dresden

04103

Universitaetsklinikum Leipzig, Leipzig

P.O.B. 12000

Hadassah University Hospita Ein Kerem, Jerusalem

00168

Policlinico Universitario Agostino Gemelli, Roma

812 8582

Kyushu University Hospital, Fukuoka

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

3015 CN

Erasmus MC, Rotterdam

3584 CX

UMC Utrecht, Utrecht

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

02 776

Instytut Hematologii i Transfuzjologii, Warsaw

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08916

Inst. Cat. D'Oncologia-Badalona, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

221 85

Skane University Hospital, Lund

141 86

Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge, Stockholm

751 85

Akademiska Sjukhuset, Uppsala

B15 2TH

Queen Elizabeth Hospital, Birmingham

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

CF14 4XW

University Hospital Wales, Cardiff

NW1 2BU

University College Hospital, London

SE5 9RS

Kings College Hospital, London

M20 4BX

Christie Hospital, Manchester

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY