International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Plasma Cell Myeloma
Interventions
DRUG

Isatuximab intravenous (IV)

Route of administration: IV infusion; Pharmaceutical form: Vial

DRUG

Cemiplimab (SAR439684)

Route of administration: IV infusion; Pharmaceutical form: Vial

DRUG

Dexamethasone

Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial

DRUG

Lenalidomide

Route of administration: Oral; Pharmaceutical form: Capsules

DRUG

Pomalidomide

Route of administration: Oral; Pharmaceutical form: Hard capsules

DRUG

Isatuximab subcutaneous (SC)

Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial

DRUG

Carfilzomib

Route of administration: IV infusion; Pharmaceutical form: Vial

Trial Locations (37)

404

Investigational Site Number : 1580001, Taichung

2025

Investigational Site Number : 5540002, Auckland

2065

Investigational Site Number : 0360001, Saint Leonards

2148

Investigational Site Number : 0360006, Blacktown

2500

Investigational Site Number : 0360003, Wollongong

3065

Investigational Site Number : 0360004, Melbourne

3084

Investigational Site Number : 0360005, Melbourne

3121

Investigational Site Number : 0360002, Richmond

6021

Investigational Site Number : 5540001, Wellington

10126

Investigational Site Number : 3800002, Torino

28027

Investigational Site Number : 7241001, Madrid

28041

Investigational Site Number : 7240003, Madrid

31008

Investigational Site Number : 7240001, Pamplona

37007

Investigational Site Number : 7240002, Salamanca

39008

Investigational Site Number : 7240004, Santander

41013

Investigational Site Number : 7240006, Seville

44093

Investigational Site Number : 2500002, Nantes

63110

Washington University- Site Number : 8400001, St Louis

125284

Investigational Site Number : 6430001, Moscow

300020

Investigational Site Number : 1560001, Tianjin

610027

Investigational Site Number : 6430002, Kirov

4780000

Investigational Site Number : 1520001, Temuco

90880-480

Hospital Mae de Deus- Site Number : 0760003, Porto Alegre

05403-010

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002, São Paulo

22775-001

Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001, Rio de Janeiro

625 00

Investigational Site Number : 2030002, Brno

708 52

Investigational Site Number : 2030003, Ostrava

128 08

Investigational Site Number : 2030001, Prague

00029

Investigational Site Number : 2460001, Helsinki

106 76

Investigational Site Number : 3000004, Athens

115 28

Investigational Site Number : 3000003, Athens

265 04

Investigational Site Number : 3000001, Pátrai

701-1192

Investigational Site Number : 3920001, Okayama

03080

Investigational Site Number : 4100001, Seoul

06591

Investigational Site Number : 4100002, Seoul

08916

Investigational Site Number : 7240005, Badalona

971 80

Investigational Site Number : 7520004, Luleå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY