531
Participants
Start Date
June 23, 2022
Primary Completion Date
November 6, 2024
Study Completion Date
March 23, 2027
Isatuximab IV
Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
Isatuximab SC
Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
Dexamethasone
Pharmaceutical form: Tablet; Route of administration: Oral
Pomalidomide
Pharmaceutical form: hard capsules; Route of administration: Oral
Dexamethasone
Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02
Montelukast
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03
Paracetamol / Acetaminophen
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01
Diphenhydramine
Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02
Methylprednisolone
Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04
Investigational Site Number : 1580005, Tainan City
Investigational Site Number : 3480002, Budapest
Investigational Site Number : 3480004, Budapest
Investigational Site Number : 0320002, Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320007, CABA
Investigational Site Number : 0320003, CABA
Investigational Site Number : 0320001, CABA
Investigational Site Number : 0320006, La Plata
Investigational Site Number : 0360007, Liverpool
Investigational Site Number : 0360004, Waratah
Investigational Site Number : 0360003, Wollongong
Investigational Site Number : 0360006, Melbourne
Investigational Site Number : 0360009, Fitzroy
Investigational Site Number : 0360001, Richmond
Investigational Site Number : 0360008, Adelaide
Investigational Site Number : 5780002, Ålesund
Investigational Site Number : 3480003, Kaposvár
Investigational Site Number : 3480008, Pécs
Investigational Site Number : 3480005, Székesfehérvár
Investigational Site Number : 3480006, Szombathely
Investigational Site Number : 1580002, Taipei
Investigational Site Number : 3000002, Athens
Investigational Site Number : 3000001, Athens
New York Oncology Hematology, P.C.- Site Number : 8400017, Albany
Investigational Site Number : 2030004, Prague
Investigational Site Number : 7520003, Stockholm
Spoknwrd Clinical Trials Inc. Site Number : 8400023, Easton
Centre for Cancer and Blood Disorders- Site Number : 8400026, Bethesda
Investigational Site Number : 2760001, Hamburg
Investigational Site Number : 2760006, Lübeck
Investigational Site Number : 2500008, Périgueux
Investigational Site Number : 3800005, Brescia
Investigational Site Number : 3000003, Pátrai
Investigational Site Number : 3800003, Pavia
Novant Health Forsyth Medical Center Site Number : 8400114, Winston-Salem
Investigational Site Number : 7240005, Madrid
Investigational Site Number : 7240007, Madrid
Novant Health- Site Number : 8400014, Charlotte
Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400002, Spartanburg
Investigational Site Number : 7240006, Murcia
Investigational Site Number : 7240001, Pamplona
Investigational Site Number : 2500003, Toulouse
Mayo Clinic- Site Number : 8400008, Jacksonville
BRCR Medical Center Inc Site Number : 8400030, Plantation
Investigational Site Number : 7920003, Istanbul
Investigational Site Number : 7920005, Istanbul
Investigational Site Number : 7920008, Istanbul
Investigational Site Number : 7920001, Istanbul
Investigational Site Number : 7920004, Bornova
Investigational Site Number : 7240002, Salamanca
Investigational Site Number : 2500007, Tours
Investigational Site Number : 7240003, Santander
Hattiesburg Clinic Site Number : 8400006, Hattiesburg
Investigational Site Number : 3800002, Bologna
Investigational Site Number : 2500009, Saint-Etienne
Investigational Site Number : 2500002, Nantes
Gabrail Cancer Center Site Number : 8400027, Canton
Oncology_Hematology Care Clinical Trials, LLC- Site Number : 8400016, Cincinnati
Investigational Site Number : 3000005, Ioannina
Investigational Site Number : 3800001, Meldola
Investigational Site Number : 7520001, Borås
UW Cancer Center at ProHealth Care Site Number : 8400001, Waukesha
Investigational Site Number : 3000004, Thessaloniki
Investigational Site Number : 3800004, Ancona
Investigational Site Number : 2030005, Brno
Investigational Site Number : 2760003, Heidelberg
Investigational Site Number : 2030006, Ostrava - Poruba
Investigational Site Number : 2500005, Paris
Texas Oncology Baylor Sammons- Site Number : 8400022, Dallas
University of Texas Southwestern- Site Number : 8400024, Dallas
Lumi Research- Site Number : 8400029, Kingwood
Investigational Site Number : 2030003, Olomouc
Texas Oncology - San Antonio- Site Number : 8400020, San Antonio
Rocky Mountain Cancer Centers, LLP- Site Number : 8400021, Aurora
Investigational Site Number : 3800007, Napoli
Investigational Site Number : 1580001, Kaohsiung City
George E. Wahlen Salt Lake City VA Medical Center- Site Number : 8400011, Salt Lake City
Investigational Site Number : 2500001, Poitiers
Arizona Oncology Associates, PC - HAL- Site Number : 8400015, Prescott Valley
Mohtaseb Cancer Center and Blood Disorders Site Number : 8400028, Bullhead City
Comprehensive Cancer Centers of Nevada- Site Number : 8400019, Las Vegas
Investigational Site Number : 3800008, Palermo
Investigational Site Number : 2760007, Nuremberg
Oncology Associates Of Oregon, P.C.- Site Number : 8400018, Eugene
Investigational Site Number : 1560001, Beijing
Investigational Site Number : 1560022, Beijing
Investigational Site Number : 1560013, Shenyang
Investigational Site Number : 1560011, Qingdao
Investigational Site Number : 1560007, Tianjin
Investigational Site Number : 1560009, Tianjin
Investigational Site Number : 1560018, Tianjin
Investigational Site Number : 1560002, Hangzhou
Investigational Site Number : 1560020, Nanchang
Investigational Site Number : 1560010, Changsha
Investigational Site Number : 1560003, Wuhan
Investigational Site Number : 1560008, Wuhan
Investigational Site Number : 1560004, Zhengzhou
Investigational Site Number : 1560006, Guangzhou
Investigational Site Number : 1560019, Nanning
Investigational Site Number : 1520001, Temuco
Investigational Site Number : 1520003, Santiago
Investigational Site Number : 1520002, Santiago
Investigational Site Number : 1520006, Santiago
Investigational Site Number : 1520004, Santiago
Atlantic Health System Site Number : 8400005, Morristown
Investigational Site Number : 0320008, CABA
Investigational Site Number : 0320005, CABA
Investigational Site Number : 0320010, Córdoba
Investigational Site Number : 0320004, Buenos Aires
Investigational Site Number : 0320009, Mendoza
NOHC - Nucleo de Oncologia e Hematologia do Ceara- Site Number : 0760006, Fortaleza
OC ONCOCLINICAS MULTIHEMO ILHA DO LEITE Site Number : 0760007, Recife
CHN - Complexo Hospitalar de Niteroi Site Number : 0760008, Niterói
Hospital Mae de Deus Site Number : 0760003, Porto Alegre
Clínica São Germano- Site Number : 0760001, São Paulo
Instituto COI de Educacao e Pesquisa- Site Number : 0760004, Rio de Janeiro
Investigational Site Number : 1240001, Toronto
Investigational Site Number : 1240004, Greenfield Park
Investigational Site Number : 1240003, Montreal
Investigational Site Number : 1520005, Viña del Mar
Investigational Site Number : 2760005, Dresden
Investigational Site Number : 3800006, Rome
Investigational Site Number : 3920001, Nagoya
Investigational Site Number : 3920007, Kamogawa-shi
Investigational Site Number : 3920005, Higashiibaraki-gun
Investigational Site Number : 3920010, Shiwa-gun
Investigational Site Number : 3920012, Kamakura-shi
Investigational Site Number : 3920003, Kyoto
Investigational Site Number : 3920006, Natori-shi
Investigational Site Number : 3920002, Okayama
Investigational Site Number : 3920011, Osaka
Investigational Site Number : 3920008, Sunto-gun
Investigational Site Number : 3920004, Shibuya-ku
Investigational Site Number : 3920009, Yamagata
Investigational Site Number : 5780001, Oslo
Investigational Site Number : 6160005, Krakow
Investigational Site Number : 6160004, Wroclaw
Investigational Site Number : 6160001, Lublin
Investigational Site Number : 7240004, Badalona
Investigational Site Number : 7920007, Ankara
Investigational Site Number : 7920009, Ankara
Investigational Site Number : 8260002, Leicester
Investigational Site Number : 8260005, London
Investigational Site Number : 8260001, Norwich
Investigational Site Number : 8260004, Birmingham
Investigational Site Number : 8260003, Derby
Lead Sponsor
Sanofi
INDUSTRY