Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

May 11, 2010

Primary Completion Date

December 21, 2018

Study Completion Date

July 13, 2023

Conditions
Hematological Malignancy
Interventions
DRUG

Isatuximab SAR650984

"Pharmaceutical form: solution for infusion~Route of administration: intravenous"

DRUG

Dexamethasone

"Pharmaceutical form: solution for infusion~Route of administration: intravenous"

DRUG

Dexamethasone

"Pharmaceutical form: tablet~Route of administration: oral"

Trial Locations (59)

34

Investigational Site Number : 604002, Lima

2060

Investigational Site Number : 056001, Antwerp

10021

Memorial Sloan-Kettering Cancer Center Site Number : 840014, New York

10126

Investigational Site Number : 380002, Torino

11528

Investigational Site Number : 300001, Athens

20520

Investigational Site Number : 246002, Turku

21001

Investigational Site Number : 804004, Vinnytsia

27707

Duke University Medical College Site Number : 840016, Durham

28041

Investigational Site Number : 724004, Madrid

30322

Emory University Site Number : 840009, Atlanta

31008

Investigational Site Number : 724002, Pamplona

31059

Investigational Site Number : 250001, Toulouse

37007

Investigational Site Number : 724001, Salamanca

37232

Vanderbilt University Site Number : 840001, Nashville

40138

Investigational Site Number : 380001, Bologna

41013

Investigational Site Number : 724008, Seville

44093

Investigational Site Number : 250003, Nantes

46017

Investigational Site Number : 724006, Valencia

48201

Karmanos Cancer Center Site Number : 840027, Detroit

52621

Investigational Site Number : 376002, Tel Litwinsky

53226

Medical College of Wisconsin Site Number : 840017, Milwaukee

55139

Investigational Site Number : 792004, Samsun

55905

Mayo Clinic of Rochester Site Number : 840018, Rochester

60637

University of Chicago Site Number : 840010, Chicago

63110

Washington University School of Medicine Site Number : 840013, St Louis

64460

Investigational Site Number : 484001, Monterrey

69495

Investigational Site Number : 250004, Pierre-Bénite

69600

Investigational Site Number : 804002, Zaporizhzhya

78419

Investigational Site Number : 484003, San Luis Potosí City

85054

Mayo Clinic Site Number : 840003, Scottsdale

91120

Investigational Site Number : 376004, Jerusalem

94117

UCSF MS Center Site Number : 840005, San Francisco

98109

Fred Hutchinson Cancer Research Center Site Number : 840012, Seattle

125284

Investigational Site Number : 643002, Moscow

185019

Investigational Site Number : 643001, Petrozavodsk

194291

Investigational Site Number : 643004, Saint Petersburg

630087

Investigational Site Number : 643003, Novosibirsk

4810469

Investigational Site Number : 152001, Temuco

48109-0759

The University Of Michigan Site Number : 840022, Ann Arbor

07601

The Cancer Center At Hackensack University Medical Site Number : 840011, Hackensack

45267-0542

University of Cincinnati Site Number : 840004, Cincinnati

84112-5550

Huntsman Cancer Institute at the University of Utah Site Number : 840002, Salt Lake City

C1425ASS

Investigational Site Number : 032003, Capital Federal

C1181ACH

Investigational Site Number : 032002, Ciudad Autonoma de Buenos Aires

C1426ANZ

Investigational Site Number : 032001, Ciudad de Buenos Aires

90110-270

Hospital Mae de Deus Site Number : 076003, Porto Alegre

14784-400

Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 076001, Barretos

04537-081

Clínica São Germano Site Number : 076002, São Paulo

22775-002

Instituto COI de Educacao e Pesquisa Site Number : 076004, Rio de Janeiro

00029

Investigational Site Number : 246001, Helsinki

Unknown

Investigational Site Number : 604001, Arequipa

Investigational Site Number : 792001, Istanbul

08036

Investigational Site Number : 724005, Barcelona

08916

Investigational Site Number : 724007, Badalona

06200

Investigational Site Number : 792002, Ankara

06500

Investigational Site Number : 792005, Ankara

04112

Investigational Site Number : 804001, Kyiv

SO16 6YD

Investigational Site Number : 826002, Southampton

NG5 1PB

Investigational Site Number : 826001, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY