337
Participants
Start Date
June 16, 2020
Primary Completion Date
October 14, 2030
Study Completion Date
October 21, 2033
Isatuximab SAR650984
Pharmaceutical for: Solution for infusion Route of administration: Intravenous
Lenalidomide
Pharmaceutical form: Capsules Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous
Montelukast or equivalent
Auxiliary Medicinal Product (AxMP)/pre-medication; ATC code: R03DC03; Pharmaceutical form: tablet; Route of administration: Oral;
Acetaminophen
AxMP/pre-medication ATC code: N02BE01 Pharmaceutical form: tablet/ampule/capsule; Route of administration: Intravenous (IV) or per os (PO)
Diphenhydramine or equivalent
AxMP/pre-medication ATC code: R06AA02 Pharmaceutical form: ampule; Route of administration: Intravenous
Methylprednisolone or equivalent
AxMP/pre-medication; ATC code: H02AB04; Pharmaceutical form: vial; Route of administration: Intravenous
Investigational Site Number :3480003, Budapest
Investigational Site Number :3480001, Budapest
Investigational Site Number :2080005, Copenhagen
Investigational Site Number :0360008, Liverpool
Investigational Site Number :0360005, Waratah
Investigational Site Number :0360001, Wollongong
Investigational Site Number :0360002, Fitzroy
Investigational Site Number :0360007, Heidelberg West
Investigational Site Number :0360004, Richmond
Investigational Site Number :5540001, Hamilton
Investigational Site Number :2080002, Roskilde
Investigational Site Number :3480002, Debrecen
Investigational Site Number :5780002, Bergen
Investigational Site Number :0360006, Nedlands
Investigational Site Number :3480004, Kaposvár
Investigational Site Number :2080003, Aarhus N
Investigational Site Number :2080001, Aalborg
Investigational Site Number :3000002, Athens
Investigational Site Number :3000001, Athens
Investigational Site Number : 2030001, Prague
Investigational Site Number :3800001, Rozzano
Investigational Site Number :2760001, Hamburg
Novant Health Forsyth Medical Center Site Number : 8401015, Winston-Salem
Investigational Site Number :7240005, Madrid
Presbyterian Hospital Site Number : 8400015, Charlotte
Investigational Site Number :7240006, Pamplona
Cancer Specialist of North Florida Site Number : 8400011, Jacksonville
University of Miami Site Number : 8400012, Miami
Investigational Site Number : 7920004, Istanbul
Investigational Site Number : 7920002, Istanbul
Investigational Site Number :2500001, Rennes
Investigational Site Number : 7920003, Izmir
Investigational Site Number :7240007, Salamanca
Tennessee Oncology Site Number : 8400006, Nashville
Investigational Site Number :2500007, Grenoble
Investigational Site Number :3800003, Bologna
Investigational Site Number :7240002, Valencia
Investigational Site Number :3800006, Meldola
Investigational Site Number :3760005, Petah Tikva
Investigational Site Number : 2030005, Hradec Králové
Investigational Site Number :7240003, Zaragoza
Investigational Site Number :2500009, Ars-Laquenexy
Investigational Site Number :2500003, Lille
Investigational Site Number :3800005, Ancona
Investigational Site Number : 2030004, Brno
Investigational Site Number :2500010, Bayonne
Investigational Site Number :3760003, Tel Aviv
Investigational Site Number :2760002, Heidelberg
Investigational Site Number : 2030003, Ostrava - Poruba
Investigational Site Number :2500005, Paris
Investigational Site Number :2500011, Paris
~University of Texas - MD Anderson Cancer Center Site Number : 8400002, Houston
Investigational Site Number : 2030002, Olomouc
Colorado Blood Cancer Institute Site Number : 8400007, Denver
Investigational Site Number :2500006, La Roche-sur-Yon
Investigational Site Number :2500002, Poitiers
UCLA Site Number : 8400010, Los Angeles
Investigational Site Number :3760001, Jerusalem
Investigational Site Number :3760002, Jerusalem
Investigational Site Number :1560005, Shenyang
Investigational Site Number :1560004, Shanghai
Investigational Site Number :1560001, Tianjin
Investigational Site Number :1560002, Hangzhou
Investigational Site Number :1560003, Hangzhou
Investigational Site Number :1560006, Nanchang
Investigational Site Number :3760006, Ramat Gan
Investigational Site Number :3760004, Ashdod
Dana Farber Cancer Institute Site Number : 8400001, Boston
Investigational Site Number :0760002, São Paulo
Investigational Site Number :1240004, Edmonton
Investigational Site Number :1240005, Moncton
Investigational Site Number :1240001, Montreal
Investigational Site Number :3000003, Thessaloniki
Investigational Site Number :3720001, Dublin
Investigational Site Number :3720002, Dublin
Investigational Site Number :3720003, Dublin
Investigational Site Number :5540004, Christchurch
Investigational Site Number :3800002, Terni
Investigational Site Number :3920002, Nagoya
Investigational Site Number :3920006, Kamogawa-shi
Investigational Site Number :3920008, Maebashi
Investigational Site Number :3920005, Higashiibaraki-gun
Investigational Site Number :3920003, Okayama
Investigational Site Number :3920009, Sunto-gun
Investigational Site Number :3920001, Shibuya-ku
Investigational Site Number :4400001, Vilnius
Investigational Site Number :5780001, Oslo
Investigational Site Number :6160006, Bydgoszcz
Investigational Site Number :6160002, Lodz
Investigational Site Number :6160008, Gdansk
Investigational Site Number :6160005, Chorzów
Investigational Site Number :4100004, Gangnam-gu
Investigational Site Number :4100003, Seoul
Investigational Site Number :4100001, Seoul
Investigational Site Number :4100002, Seoul
Investigational Site Number :7240004, Barcelona
Investigational Site Number :7240001, Barcelona
Investigational Site Number :7520001, Gothenburg
Investigational Site Number :7520003, Helsingborg
Investigational Site Number : 7920005, Ankara
Investigational Site Number : 7920001, Ankara
Investigational Site Number :8260002, Bournemouth
Investigational Site Number :8260003, London
Investigational Site Number :8260001, Leicester
Investigational Site Number :8260004, Southampton
Lead Sponsor
Sanofi
INDUSTRY