A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

475

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

April 5, 2026

Study Completion Date

June 30, 2027

Conditions
Plasma Cell Myeloma
Interventions
DRUG

Isatuximab SAR650984

"Pharmaceutical form: Solution for infusion~Route of administration: Intravenous (IV)"

DRUG

Bortezomib

"Pharmaceutical form: Lyophilized powder for injection~Route of administration: Subcutaneous"

DRUG

Lenalidomide

"Pharmaceutical form: Capsules~Route of administration: Oral"

DRUG

Dexamethasone

"Pharmaceutical form: Tablets, ampoules or vials for injection~Route of administration: Oral/Intravenous"

Trial Locations (104)

100

Investigational Site Number : 1580001, Taipei

500

Investigational Site Number : 1580003, Changhua

1070

Investigational Site Number : 6200001, Lisbon

1309

Investigational Site Number : 5540002, Takapuna

2025

Investigational Site Number : 5540001, Auckland

2170

Investigational Site Number : 0360003, Liverpool

2298

Investigational Site Number : 0360001, Waratah

2500

Investigational Site Number : 0360002, Wollongong

3081

Investigational Site Number : 0360004, Heidelberg West

3168

Investigational Site Number : 0360005, Clayton

3204

Investigational Site Number : 5540003, Hamilton

4000

Investigational Site Number : 0560001, Liège

4101

Investigational Site Number : 0360007, South Brisbane

4200

Investigational Site Number : 6200003, Porto

5000

Investigational Site Number : 2080004, Odense C

6005

Investigational Site Number : 0360008, West Perth

6009

Investigational Site Number : 0360006, Nedlands

8200

Investigational Site Number : 2080003, Aarhus N

9000

Investigational Site Number : 2080002, Aalborg

10126

Investigational Site Number : 3800002, Torino

10676

Investigational Site Number : 3000003, Athens

11528

Investigational Site Number : 3000001, Athens

12808

Investigational Site Number : 2030001, Prague

13125

Investigational Site Number : 2760003, Berlin

14033

Investigational Site Number : 2500007, Caen

14186

Investigational Site Number : 7520001, Stockholm

21000

Investigational Site Number : 2500009, Dijon

24127

Investigational Site Number : 3800003, Bergamo

25123

Investigational Site Number : 3800004, Brescia

28034

Investigational Site Number : 7240003, Madrid

30008

Investigational Site Number : 7240001, Murcia

30599

Investigational Site Number : 2030006, Pilsen

31059

Investigational Site Number : 2500004, Toulouse

33600

Investigational Site Number : 2500002, Pessac

33705

Investigational Site Number: 8400004, St. Petersburg

33901

Investigational Site Number: 8400006, Fort Myers

34390

Investigational Site Number : 7920002, Istanbul

35040

Investigational Site Number : 7920004, Izmir

35340

Investigational Site Number : 7920003, Izmir

37203

Investigational Site Number: 8400005, Nashville

38039

Investigational Site Number : 7920005, Kayseri

40138

Investigational Site Number : 3800001, Bologna

40447

Investigational Site Number : 1580002, Taichung

44093

Investigational Site Number : 2500003, Nantes

50005

Investigational Site Number : 2030007, Hradec Králové

54511

Investigational Site Number : 2500010, Vandœuvre-lès-Nancy

55139

Investigational Site Number : 7920008, Samsun

57010

Investigational Site Number : 3000002, Thessaloniki

59037

Investigational Site Number : 2500001, Lille

60032

Investigational Site Number : 3800005, Ancona

60590

Investigational Site Number : 2760004, Frankfurt am Main

62500

Investigational Site Number : 2030002, Brno

64100

Investigational Site Number : 2500011, Bayonne

64132

Investigational Site Number: 8400007, Kansas City

64460

Investigational Site Number : 4840001, Monterrey

69120

Investigational Site Number : 2760001, Heidelberg

69495

Investigational Site Number : 2500006, Pierre-Bénite

70852

Investigational Site Number : 2030003, Ostrava - Poruba

72076

Investigational Site Number : 2760005, Tübingen

75012

Investigational Site Number : 2500012, Paris

77030

Investigational Site Number: 8400001, Houston

77900

Investigational Site Number : 2030004, Olomouc

85925

Investigational Site Number : 2500008, La Roche-sur-Yon

86021

Investigational Site Number : 2500005, Poitiers

100034

Investigational Site Number : 1560002, Beijing

100191

Investigational Site Number : 1560003, Beijing

110022

Investigational Site Number : 1560011, Shenyang

125284

Investigational Site Number : 6430001, Moscow

129301

Investigational Site Number : 6430002, Moscow

130021

Investigational Site Number : 1560008, Changchun

200025

Investigational Site Number : 1560013, Shanghai

210029

Investigational Site Number : 1560004, Nanjing

300020

Investigational Site Number : 1560001, Tianjin

310003

Investigational Site Number : 1560005, Hangzhou

Investigational Site Number : 1560014, Hangzhou

350001

Investigational Site Number : 1560007, Fuzhou

430022

Investigational Site Number : 1560012, Wuhan

510060

Investigational Site Number : 1560009, Guangzhou

510080

Investigational Site Number : 1560006, Guangzhou

467-8602

Investigational Site Number : 3920007, Nagoya

311-3193

Investigational Site Number : 3920004, Higashiibaraki-gun

234-0054

Investigational Site Number : 3920008, Konan-ku, Yokohama-shi

860-8556

Investigational Site Number : 3920003, Kumamoto

983-8520

Investigational Site Number : 3920009, Sendai

701-1192

Investigational Site Number : 3920005, Okayama

411-8777

Investigational Site Number : 3920006, Sunto-gun

150-8935

Investigational Site Number : 3920001, Shibuya-ku

162-8666

Investigational Site Number : 3920002, Shinjuku-ku

990-9585

Investigational Site Number : 3920010, Yamagata

LT-92288

Investigational Site Number : 4400002, Klaipėda

08661

Investigational Site Number : 4400001, Vilnius

60-631

Investigational Site Number : 6160004, Poznan

93-510

Investigational Site Number : 6160003, Lodz

02-781

Investigational Site Number : 6160001, Warsaw

80-952

Investigational Site Number : 6160002, Gdansk

4710-243

Investigational Site Number : 6200002, Braga

3000-075

Investigational Site Number : 6200006, Coimbra

4200-319

Investigational Site Number : 6200005, Porto

08035

Investigational Site Number : 7240005, Barcelona

08041

Investigational Site Number : 7240004, Barcelona

221 85

Investigational Site Number : 7520002, Lund

01250

Investigational Site Number : 7920006, Adana

06500

Investigational Site Number : 7920007, Ankara

06620

Investigational Site Number : 7920001, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY