A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

522

Participants

Timeline

Start Date

October 27, 2017

Primary Completion Date

June 27, 2019

Study Completion Date

January 12, 2024

Conditions
Multiple Myeloma
Interventions
DRUG

Dara SC

Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

DRUG

Dara IV

Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

Trial Locations (146)

704

National Cheng Kung University Hospital, Tainan City

2050

Royal Prince Alfred Hospital, Camperdown

2298

Calvary Mater Newcastle Hospital, Waratah

3004

Alfred Health, Melbourne

3065

St Vincents Hospital Melbourne, Fitzroy

4102

Princess Alexandra Hospital, Woolloongabba

5011

The Queen Elizabeth Hospital, Woodville South

6009

Sir Charles Gairdner Hospital, Nedlands

6150

Fiona Stanley Hospital, Murdoch

10048

National Taiwan University Hospital, Taipei

10126

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

10408

National Cancer Center, Goyang-si

14033

CHU Caen - Côte de Nacre, Caen

17007

Hosp. Univ. Dr. Josep Trueta, Girona

18009

Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council', Cherkasy

18014

Hosp. Univ. Virgen de Las Nieves, Granada

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

21565

Gachon University Gil Medical Center, Incheon

24008

Hosp. de Leon, León

25187

Helsingborgs lasarett, Helsingborg

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28031

Hosp. Univ. Infanta Leonor, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

28223

Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón

29121

Azienda USL di Piacenza, Piacenza

31008

Clinica Univ. de Navarra, Pamplona

31096

Rambam Med.Center - Hematology Institute, Haifa

33305

Chang Gung Memorial Hospital, Taoyuan District

33604

CHU de Boreaux, Pessac

36011

Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital, Poltava

37007

Hosp Clinico Univ de Salamanca, Salamanca

38100

Hillel Yaffe Medical Center - Oncology, Hadera

38320

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

40138

Policlinico Sant'Orsola Malpighi, Bologna

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

44033

Ulsan University Hospital, Ulsan

44093

CHU de Nantes hotel Dieu, Nantes

46017

Hosp. Univ. Dr. Peset, Valencia

49100

Rabin Medical Center Beilinson Campus, Petah Tikva

49102

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center, Dnipro

49241

Pusan National University Hospital, Busan

50006

Chang-Hua Christian Hospital, Changhua

52621

Sheba Medical Center Tel Hashomer, Ramat Gan

54000

Mykolaiv Regional Clinical Hospital, Mykolaiv

54511

CHU Nancy Brabois, Vandœuvre-lès-Nancy

59000

Hopital Claude Huriez, Lille

61024

SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine, Kharkiv

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

70852

Fakultni Nemocnice Ostrava, Ostrava

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

79044

Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine, Lviv

79182

Falu Lasarett, Falun

86021

CHU Poitiers - Hopital la Miletrie, Poitiers

90146

Ospedale Villa Sofia-Cervello, Palermo

91120

Hadassah Medical Center, Jerusalem

123182

Saint Petersburg City Hospital #15, Saint Petersburg

125284

S.P. Botkin Moscow City Clinical Hospital, Moscow

129301

City Clinical Hospital # 40, Moscow

167904

Oncology Dispensary of Komi Republic, Syktyvkar

191024

Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg

390039

Ryazan Regional Clinical Hospital, Ryazan

440071

Penza Regional Oncology Dispensary, Penza

443095

Samara Region Clinical Hospital, Samara

603126

Nizhniy Novgorod Region Clinical Hospital, Nizny Novgorod

606019

Emergency Hospital of Dzerzhinsk, Dzerzhinsk

620137

Ekaterinburg City Clinical Hospital # 7, Yekaterinburg

3436212

Carmel Medical Center, Haifa

02215-5418

Dana Farber Cancer Institute, Boston

14784-400

Fundacao Pio XII, Barretos

88034-000

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN, Florianópolis

17210 080

Fundacao Doutor Amaral Carvalho, Jaú

89201-260

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia, Joinville

99010-090

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo, Passo Fundo

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

22775-001

Instituto de Educacao, Pesquisa e Gestao em Saude, Rio de Janeiro

45995-000

CEHON, 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

05403-010

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

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 1M9

The Gordon & Leslie Diamond Health Care Center, Vancouver

B3H 1V7

QEII Health Sciences Centre, Halifax

N6A 5W9

Victoria Hospital, London

M5G 1X6

Princess Margaret Hospital, Toronto

G1R 2J6

CHU de Quebec L Hotel Dieu de Quebec, Québec

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

779 00

Fakultni nemocnice Olomouc, Olomouc

323 00

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni, Pilsen

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie, Prague

115 28

Alexandra General Hospital of Athens, Athens Attica

00161

Università di Roma La Sapienza, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

814-0180

Fukuoka University Hospital, Fukuoka

720-0001

Chugoku Central Hospital, Fukuyama

503-8502

Ogaki Municipal Hospital, Gifu

371-0034

Gunma University Hospital, Gunma

650 0047

Kobe City Medical Center General Hospital, Kobe

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

790-8524

Matsuyama Red Cross Hospital, Matsuyama

466-8650

Japanese Red Cross Nagoya Daini Hospital, Nagoya

467 8602

Nagoya City University Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, Niigata

020-8505

Iwate Medical University Hospital, Numakunai

701-1192

National Hospital Organization Okayama Medical Center, Okayama

565-0871

Osaka University Hospital, Osaka

983-8520

National Hospital Organization Sendai Medical Center, Sendai

377-0280

National Hospital Organization Shibukawa Medical Center, Shibukawa

150-8935

Japanese Red Cross Medical Center, Shibuya City

36-200

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza, Brzozów

85-168

Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy, Bydgoszcz

41-500

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzów

81 519

Szpitale Pomorskie Sp z o o, Gdynia

31 501

Szpital Uniwersytecki w Krakowie, Krakow

59-220

Wojewodzki Szpital Specjalistyczny w Legnicy, Legnica

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

60 569

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im Karola Marcinkowskiego, Poznan

02-781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

141 86

Karolinska University Hospital Huddinge, Huddinge

222 41

Skanes universitetssjukhus, Lund

907 46

Norrlands University Hospital, Umeå

SE-751 85

Akademiska Sjukhuset, Uppsala

03022

National Cancer Institute, Dept. of chemotherapy of hemoblastosis, Kiev

03115

Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department, Kiev

State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine', Kiev

FY3 8NR

Blackpool Victoria Hospital, Blackpool

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

LE1 5WW

Leicester Royal Infirmary - Haematology, Leicester

EC1A 7BE

St Bartholomew's Hospital, London

SE1 9RT

Guys St Thomas Hospital, London

M20 9BX

Christie Hospital NHS Trust, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

SM2 5PT

Royal Marsden Hospital, Surrey

WV10 0QP

New Cross Hospital, Wolverhampton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03277105 - A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter