- 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)
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