A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

PHASE2RecruitingINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

February 20, 2026

Study Completion Date

May 12, 2028

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

Isatuximab

Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous

DRUG

Carfilzomib

Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

DRUG

Dexamethasone

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Dexamethasone IV

Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous

DRUG

Montelukast

Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral

DRUG

Acetaminophen

Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)

DRUG

Diphenhydramine

Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV

DRUG

Methylprednisolone

Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV

Trial Locations (23)

2500

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360002, Wollongong

3065

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360001, Fitzroy

10676

RECRUITING

Investigational Site Number : 3000001, Athens

11528

RECRUITING

Investigational Site Number : 3000002, Athens

12808

RECRUITING

Investigational Site Number : 2030001, Prague

62500

RECRUITING

Investigational Site Number : 2030002, Brno

70852

RECRUITING

Investigational Site Number : 2030003, Ostrava - Poruba

77900

RECRUITING

Investigational Site Number : 2030004, Olomouc

110022

RECRUITING

Investigational Site Number : 1560004, Shenyang

300020

RECRUITING

Investigational Site Number : 1560001, Tianjin

300060

RECRUITING

Investigational Site Number : 1560007, Tianjin

330006

RECRUITING

Investigational Site Number : 1560005, Nanchang

410013

RECRUITING

Investigational Site Number : 1560006, Changsha

430030

RECRUITING

Investigational Site Number : 1560003, Wuhan

510060

RECRUITING

Investigational Site Number : 1560002, Guangzhou

90110-270

RECRUITING

Hospital Mae de Deus Site Number : 0760002, Porto Alegre

04537-081

RECRUITING

Clinica Sao Germano- Site Number : 0760003, São Paulo

05403-000

RECRUITING

Hospital das Clinicas de Sao Paulo- Site Number : 0760001, São Paulo

277-8577

ACTIVE_NOT_RECRUITING

Investigational Site Number : 3920001, Kashiwa-shi

701-1192

ACTIVE_NOT_RECRUITING

Investigational Site Number : 3920002, Okayama

4710-243

ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200001, Braga

1400-038

ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200004, Lisbon

1649-035

ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200005, Lisbon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY