A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

PHASE3CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

October 5, 2017

Primary Completion Date

February 14, 2020

Study Completion Date

November 19, 2024

Conditions
Amyloidosis
Interventions
DRUG

Cyclophosphamide

Participants will receive 300 mg/m\^2 of cyclophosphamide as an oral or IV dose.

DRUG

Bortezomib

Participants will receive 1.3 mg/m\^2 of bortezomib as an subcutaneous (SC) injection.

DRUG

Dexamethasone, 40 mg

Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.

DRUG

Daratumumab

Participants will receive 1800 mg of daratumumab subcutaneously.

Trial Locations (140)

1070

Institut Jules Bordet, Anderlecht

1083

Semmelweis Egyetem I.Belgyogyaszati Klinika, Budapest

1088

Semmelweis Egyetem I.Belgyogyaszati Klinika, Budapest

1097

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

2145

Westmead Hospital, Westmead

2400

Dep. of Hematology, Rigshospitalet, Copenhagen

3000

Universitair Ziekenhuis Leuven, Leuven

3128

Box Hill Hospital, Box Hill

4102

Princess Alexandra Hospital, Woolloongabba

5000

Odense Universitets Hospital, Odense

6009

Sir Charles Gairdner Hospital, Nedlands

7059

Akdeniz University Medical Faculty, Antalya

8500

Az Groeninge, Kortrijk

9000

UZ Gent, Ghent

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medical College, New York

10126

A.O.U. Città della Salute e della Scienza, Torino

11528

Alexandra General Hospital of Athens, Athens

12203

Charite Campus Benjamin Franklin, Berlin

13273

Institut Paoli Calmettes, Marseille

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania Medical Center, Philadelphia

21000

CHU Dijon, Dijon

21201

University of Maryland, Baltimore

22767

HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH, Hamburg

26500

University General Hospital of Rio, Pátrai

27100

Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo, Pavia

27157

Wake Forest University Health Sciences - Cardiovascular Medicine, Winston-Salem

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28040

Hosp Univ Fund Jimenez Diaz, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

30322

Winship Cancer Institute Emory University, Atlanta

31008

Clinica Univ. de Navarra, Pamplona

31400

CHU Rangueil, Toulouse

32224

Mayo Clinic, Jacksonville

34093

Istanbul University Istanbul Medical Faculty, Istanbul

34362

Carmel Hospital, Haifa

35340

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

37007

Hosp Clinico Univ de Salamanca, Salamanca

37044

CHU Bretonneau, Tours

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University Medical Center, Nashville

38039

Erciyes University Medical Faculty, Talas

38320

Hosp. Univ. de Canarias, San Cristóbal de La Laguna

40138

Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi, Bologna

40225

Heinrich-Heine-Universität Düsseldorf, Düsseldorf

43210

The Ohio State University, Columbus

44035

Chu Hotel Dieu, Nantes

44160

Centro de Investigación Farmacéutica Especializada, Guadalajara

44195

Cleveland Clinic, Cleveland

45122

Universitatsklinikum Essen, Essen

46017

Hosp. Univ. Dr. Peset, Valencia

48201

Barbara Ann Karmanos Cancer Institute, Detroit

49241

Pusan National University Hospital, Busan

52621

Sheba Medical Center, Ramat Gan

54511

CHU de Nancy_ Hopital Brabois, Vandœuvre-lès-Nancy

55270

Ondokuz Mayis Universitesi Tip Fakultesiy, Atakum

55905

Mayo Clinic Rochester, Rochester

59037

Hopital Claude Huriez, Lille

63110

Washington University School Of Medicine, St Louis

64460

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey

69120

Universitaetsklinikum Heidelberg Medizinische Klinik V, Heidelberg

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

70124

Policlinico di Bari, Bari

70300

Assaf Ha'Rofeh Medical Center, Ẕerifin

72076

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,, Tübingen

75475

Hopital Saint Louis, Paris

77030

University of Texas, MD Anderson Cancer Center, Houston

80045

University of Colorado, Aurora

80218

Colorado Blood Cancer Institute, Denver

84112

Huntsman Cancer Institute, Salt Lake City

85054

Mayo Clinic Arizona, Phoenix

86000

CHU De Poitiers, Poitiers

87000

CHU de Limoges - Fédération Hépatologie, Limoges

90146

Casa di Cura La Maddalena, Palermo

91010

City of Hope, Duarte

91120

Hadassah Medical Center, Jerusalem

94143

University of California San Francisco, San Francisco

94305

Stanford University, Stanford

97080

Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii, Würzburg

97239

Oregon Health And Science University, Portland

100034

Peking University First Hospital, Beijing

100044

Peking University People s Hospital, Beijing

200025

Ruijin Hospital Shanghai Jiao Tong University, Shanghai

310020

First affiliated Hospital of Zhejiang University, Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

6423906

Sourasky Medical Center, Tel Aviv

02111

Tufts Medical Center, Boston

02118

Boston University Medical Center, Boston

02215-5418

Dana Farber Cancer Institute, Boston

98109-1023

Seattle Cancer Care Alliance, Seattle

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

50040-000

Sociedade Pernambucana de Combate ao Cancer, Recife

22775 001

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro

41253 190

Hospital Sao Rafael, Salvador

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base, São José do Rio Preto

01455 010

Clinica Sao Germano, São Paulo

04039-004

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, São Paulo

05403-010

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

T2N 5G2

Arthur J E Child Comprehensive Cancer Centre, Calgary

T6G 1Z2

Alberta Health Services, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

N6A 5W9

London Health Sciences Center, London

M5G 2M9

University Health Network UHN Princess Margaret Cancer Centre, Toronto

H4A 3J1

McGill University Health Centre, Montreal

DK-8200

Aarhus University Hospital, Aarhus N

00161

Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I, Roma

960 1295

Fukushima Medical University Hospital, Fukushima

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima

006-8555

Teine Keijinkai Hospital, Hokkaido

920 8641

Kanazawa University Hospital, Kanazawa

860-8556

Kumamoto University Hospital, Kumamoto

603-8151

Kyoto Kuramaguchi Medical Center, Kyoto

390 8621

Shinshu University Hospital, Matsumoto

790-8524

Matsuyama Red Cross Hospital, Matsuyama

467 8602

Nagoya City University Hospital, Nagoya

701-1192

National Hospital Organization Okayama Medical Center, Okayama

150-8935

Japanese Red Cross Medical Center, Shibuya City

770-8503

Tokushima University Hospital, Tokushima

9713 GZ

UMCG, Groningen

3015 CN

Erasmus MC, Rotterdam

2545 AA

Haga ziekenhuis, The Hague

3584 CX

UMC Utrecht, Utrecht

5504 DB

Maxima Medisch Centrum, Veldhoven

41-500

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzów

60-569

SKPP UM w Poznaniu, Poznan

02 776

Instytut Hematologii i Transfuzjologii, Warsaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08916

Inst. Cat. D'Oncologia-Badalona, Badalona

08035

Hosp Univ Vall D Hebron, Barcelona

08036

Hosp Clinic de Barcelona, Barcelona

501 82

South Elvsborg Hospital, Borås

221 85

Skanes universitetssjukhus, Lund

06590

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara

B15 2TH

University Hospitals Birmingham NHS Trust,, Birmingham

NW1 2PG

University College Hospital, London

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03201965 - A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | Biotech Hunter | Biotech Hunter