Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05704049
PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.

Official title: A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2023-04-05

Completion Date

2028-05-12

Last Updated

2025-12-29

Healthy Volunteers

No

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

Locations (23)

Investigational Site Number : 0360002

Wollongong, New South Wales, Australia

Investigational Site Number : 0360001

Melbourne, Victoria, Australia

Hospital Mae de Deus Site Number : 0760002

Porto Alegre, Rio Grande do Sul, Brazil

Clinica São Germano- Site Number : 0760003

São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

São Paulo, Brazil

Investigational Site Number : 1560006

Changsha, China

Investigational Site Number : 1560002

Guangzhou, China

Investigational Site Number : 1560005

Nanchang, China

Investigational Site Number : 1560004

Shenyang, China

Investigational Site Number : 1560001

Tianjin, China

Investigational Site Number : 1560007

Tianjin, China

Investigational Site Number : 1560003

Wuhan, China

Investigational Site Number : 2030002

Brno, Czechia

Investigational Site Number : 2030004

Olomouc, Czechia

Investigational Site Number : 2030003

Ostrava, Czechia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000002

Athens, Greece

Investigational Site Number : 3920001

Kashiwa, Chiba, Japan

Investigational Site Number : 3920002

Okayama, Japan

Investigational Site Number : 6200001

Braga, Portugal

Investigational Site Number : 6200004

Lisbon, Portugal

Investigational Site Number : 6200005

Lisbon, Portugal