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  • Active, not recruiting

NCT02990338: Phase 3 - Isatuximab, Pomalidomide & Dex VS Pom & Dex in relapsed Myeloma (ICARIA-MM)

Updated: Aug 26, 2022

ICARIA

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)

Icaria trial

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)


Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM).

Secondary Objectives:

To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.

To compare the Overall Survival (OS) between the two arms.

To evaluate the Time To Progression (TTP) in each arm.

To evaluate the PFS in high risk cytogenetic population in each arm.

To evaluate the Duration of Response (DOR) in each arm.

To evaluate the safety in both treatment arms.

To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.

To evaluate the immunogenicity of isatuximab.

To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.


Multiple Locations

International study

 

ClinicalTrials.gov Identifier: NCT02990338

Official Title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

First Posted: December 13, 2016


Click here for details on ClinicalTrials.gov

 
 

Drug: Isatuximab

Drug: Pomalidomide

Drug: Dexamethasone

 

Publications:


Lancet. 2019 Dec 7


Leuk Res. 2021 May


Haematologica. 2021 Apr 1

 

OAB-052 Isatuximab Plus Pomalidomide/Low-Dose Dexamethasone Versus Pomalidomide/Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (ICARIA-MM): Final Overall Survival Analysis -Paul Richardson


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California


 

Locations

United States, Florida

United States, Massachusetts

Canada, Quebec

Australia, New South Wales

Australia, Victoria

New Zealand

Europe

United Kingdom

Belgium

Europe

Czechia

Denmark

France

Germany

Greece

Hungary

Italy

Norway

Poland

Portugal

Slovakia

Spain

Sweden

Turkey

Asia

Japan

Korea, Republic of

Russian Federation

Taiwan


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