A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

May 1, 2024

Study Completion Date

June 30, 2026

Conditions
Smoldering Multiple Myeloma
Interventions
DRUG

Daratumumab SC: daratumumab + rHuPH20

Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 \[2000 U/mL\]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.

Trial Locations (163)

1083

Semmelweis Egyetem, I. Belgyogyaszati Klinika, Budapest

1088

Semmelweis Egyetem I.Belgyogyaszati Klinika, Budapest

1090

UZBrussel, Brussels

1097

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

1431

CEMIC Saavedra, Ciudad de Buenos Aires

2000

Sanatorio Britanico de Rosario, Rosario

2060

ZNA, Antwerp

2100

Rigshospitalet, Copenhagen

2298

Calvary Mater Newcastle Hospital, Waratah

3500

Virga Jessa Ziekenhuis, Hasselt

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5000

Odense Universitetshospital, Odense C

5011

Queen Elizabeth Hospital, Woodville

6005

The Perth Blood Institute, West Perth

6100

Ankara University Medical Faculty, Ankara

8000

AZ St.-Jan Brugge-Oostende AV, Bruges

8035

Hosp Univ Vall D Hebron, Barcelona

8200

Aarhus University Hospital, Aarhus N

8500

Az Groeninge, Kortrijk

9000

UZ Gent, Ghent

Ålborg Universitetshospital, Aalborg

10126

A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia, Torino

11794

Stony Brook University Medical Center, Stony Brook

12100

A.O. Santa Croce e Carle, Cuneo

12206

New York Oncology Hematology, Albany

13125

Helios Kliniken Berlin Buch Gmbh, Berlin

18101

Haemek, Afula

19111

Fox Chase Cancer Center, Philadelphia

20121

iBiomed Research Unit, Aguascalientes

21100

ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi, Varese

22030

Trakya University Hospital, Edirne

22100

Galilee Medical Center, Nahariya

27599

University of North Carolina, Chapel Hill

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28031

Hosp. Univ. Infanta Leonor, Madrid

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28204

Levine Cancer Institute, Carolinas HealthCare System, Charlotte

28223

Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón

30322

Emory University, Atlanta

31008

Clinica Univ. de Navarra, Pamplona

31048

Bnai Zion Medical Center, Haifa

33176

Miami Cancer Institute, Miami

33604

CHU de Bordeaux - Hospital Haut-Leveque, Pessac

34093

Istanbul University Istanbul Medical Faculty, Istanbul

35033

l'Hôpital Pontchaillou, Rennes

37007

Hosp Clinico Univ de Salamanca, Salamanca

37044

CHU Bretonneau, Tours

38030

Erciyes University Medical Faculty, Kayseri

40138

Policlinico Sant'Orsola Malpighi, Bologna

43210

The Ohio State University, Columbus

44035

Chu Hotel Dieu, Nantes

44160

Centro de Investigación Farmacéutica Especializada, Guadalajara

44195

Cleveland Clinic, Cleveland

46017

Hosp. Univ. Dr. Peset, Valencia

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48149

Medizinische Klinik A, Münster

49100

Rabin Medical Center, Petah Tikva

52242

University of Iowa Hospitals and Clinics, Iowa City

52621

Sheba Medical Center, Ramat Gan

55139

Ondokuz Mayis University, Samsun

55905

Mayo Clinic, Rochester

59073

St. Barbara-Klinik Hamm GmbH, Hamm

62290

JM Research, SC, Cuernavaca

63110

Washington University, St Louis

64460

Hospital Universitario de Nuevo León, Monterrey

69120

Universitaetsklinikum Heidelberg Medizinische Klinik V, Heidelberg

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

70006

East Jefferson General Hospital, Metairie

70852

Fakultni Nemocnice Ostrava, Ostrava

72076

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

75216

VA North Texas Health Care System, Dallas

75702

Texas Oncology P A, Tyler

78705

Texas Oncology P A, Austin

78741

Barzilai Medical Center, Ashkelon

79182

Falu Lasarett, Falun

85016

Arizona Oncology Associates, PC - HAL, Phoenix

86021

CHU De Poitiers, Poitiers

87000

CHU de Limoges - Fédération Hépatologie, Limoges

89081

Universitaetsklinikum Ulm, Ulm

89086

VA Southern Nevada Healthcare, North Las Vegas

90805

Innovative Clinical Research Inc, Whittier

University of Washington, Seattle

97134

Centro de Atención e Investigación Clínica en Oncología, Mérida

97180

Sunderby Sjukhus Medicinkliniken, Luelå

97239

OHSU/CHM, Portland

125284

City clinical hospital n.a. S.P.Botkin, Moscow

129301

City Clinical Hospital # 40, Moscow

167904

Oncology Dispensary of Komi Republic, Syktyvkar

185019

Republican Hospital n.a.V.A.Baranov, Petrozavodsk

191024

Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg

390003

Ryazan Regional Clinical Hospital, Ryazan

603126

Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod

606019

Emergency Hospital of Dzerzhinsk, Dzerzhinsk

614078

Perm Medical Sanitary Unit#1, Perm

3436212

Carmel Medical Center, Haifa

3525408

Rambam Medical Center, Haifa

6423906

Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

02215-5418

Dana Farber Cancer Institute, Boston

C1118AAT

Hospital Aleman, Buenos Aires

C1199ABD

Hospital Italiano de Buenos Aires, Buenos Aires

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

B1900AXI

Hospital Italiano de La Plata, La Plata

3150 or 3084

Austin Hospital, Heidelberg

88034-000

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

74605-020

Universidade Federal de Goias - Hospital das Clinicas da UFG, Goiânia

89201-260

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

90035-003

Hospital das Clinicas de Porto Alegre, Porto Alegre

22775-002

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

41235-190

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

01236-030

Instituto de Ensino e Pesquisa São Lucas, São Paulo

01455 010

Clinica Sao Germano, São Paulo

04122-000

Hospital Santa Cruz, São Paulo

T2N 5G2

Arthur J E Child Comprehensive Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

L1G-2B9

Lakeridge Health Oshawa, Oshawa

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

323 00

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni, Pilsen

128 08

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

115 28

Alexandra General Hospital of Athens, Athens Attica

09121

Businco Cancer Hospital, Cagliari

00144

Ospedale S. Eugenio, Roma

00161

Università di Roma 'La Sapienza' - Ospedale Umberto 1°, Roma

814-0180

Fukuoka University Hospital, Fukuoka

720-0001

Chugoku Central Hospital, Fukuyama

503-8502

Ogaki Municipal Hospital, Gifu

890-8520

Kagoshima University Hospital, Kagoshima

920 8641

Kanazawa University Hospital, Kanazawa

586 8521

National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano

650 0047

Kobe City Medical Center General Hospital, Kobe

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

830-0011

Kurume University Hospital, Kurume

603-8151

Kyoto Kuramaguchi Medical Center, Kyoto

399-8701

National Hospital Organization Matsumoto Medical Center, Matsumoto

790-8524

Matsuyama Red Cross Hospital, Matsuyama

467 8602

Nagoya City University Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, Niigata

701-1192

National Hospital Organization Okayama Medical Center, Okayama

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

7334 DZ

Gelre Ziekenhuis, Apeldoorn

3318 AT

Albert Schweitzer Ziekenhuis, Dordrecht

2545 AA

Haga ziekenhuis, The Hague

5042 AD

ETZ TweeSteden, Tilburg

0450

Oslo University Hospital HF Ulleval sykehus, Oslo

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

59-220

Wojewodzki Szpital Specjalistyczny w Legnicy, Legnica

61 731

Clinical Research Center Sp z o o Medic R Sp k, Poznan

02 776

Instytut Hematologii i Transfuzjologii, Warsaw

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

06230

Ankara Numune Egitim ve Arastirma Hastanesi, Ankara

B9 5SS

Heart of England NHS Foundation Trust, Birmingham

BS2 8ED

University Hospitals Bristol NHS Trust, Bristol

CT1 3NG

Kent and Canterbury Hospital, Canterbury

EC1A 7BE

St Bartholomew's Hospital, London

M20 4BX

Christie Hospital NHS Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

ST4 6QG

Royal Stoke University Hospital, Stoke-on-Trent

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY