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A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Sponsor: Sanofi
Summary
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
583
Start Date
2020-08-13
Completion Date
2026-02-23
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
isatuximab SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pomalidomide
Pharmaceutical form: oral
Dexamethasone
Pharmaceutical form: oral
Carfilzomib
Pharmaceutical form: solution for infusion
Locations (129)
University of Arkansas Medical Sciences Site Number : 8400021
Little Rock, Arkansas, United States
St. Joseph Heritage Healthcare Site Number : 8400008
Fullerton, California, United States
University of California San Francisco (PARENT) Site Number : 8400009
San Francisco, California, United States
Holy Cross Hospital Site Number : 8400030
Fort Lauderdale, Florida, United States
GenesisCare Site Number : 8400007
Jacksonville, Florida, United States
Watson Clinic Cancer and Research Center Site Number : 8400023
Lakeland, Florida, United States
Millennium Oncology Site Number : 8400025
Pembroke Pines, Florida, United States
Comprehensive Hematology Oncology Site Number : 8400026
St. Petersburg, Florida, United States
Central Care Cancer Center Site Number : 8400019
Garden City, Kansas, United States
Central Maine Medical Center Site Number : 8400031
Lewiston, Maine, United States
Michigan Center of Medical Research Site Number : 8400010
Farmington Hills, Michigan, United States
Central Care Cancer Center Site Number : 8400006
Garden City, Missouri, United States
AMR Kansas City Site Number : 8400016
Kansas City, Missouri, United States
Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
Freehold, New Jersey, United States
Regional Cancer Care Associates Site Number : 8400024
Howell Township, New Jersey, United States
Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
Little Silver, New Jersey, United States
Novant Health Forsyth Medical Center Site Number : 8400028
Winston-Salem, North Carolina, United States
Hematology & Oncology Associates Site Number : 8400015
Canton, Ohio, United States
Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
Massillon, Ohio, United States
Charleston Hematology Oncology Associates, PA Site Number : 8400020
Charleston, South Carolina, United States
Prisma Health - Eastside Office Site Number : 8400011
Greenville, South Carolina, United States
Prairie Lakes Health Care System, Inc Site Number : 8400002
Watertown, South Dakota, United States
MD Anderson Cancer Center Site Number : 8400013
Houston, Texas, United States
Renovatio Clinical Site Number : 8400004
The Woodlands, Texas, United States
Investigational Site Number : 0320001
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320006
Pilar, Buenos Aires, Argentina
Investigational Site Number : 0320004
Buenos Aires, Argentina
Investigational Site Number : 0320005
Córdoba, Argentina
Investigational Site Number : 0320002
Córdoba, Argentina
LKH Steyr - Investigational Site Number : 0400002
Steyr, Austria
Institut Jules Bordet - Investigational Site Number : 0560001
Anderlecht, Belgium
AZ Nikolaas - Investigational Site Number : 0560002
Sint-Niklaas, Belgium
Investigational Site Number : 1560002
Guangzhou, China
Investigational Site Number : 1560001
Shenzhen, China
Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
Argenteuil, France
Investigational Site Number : 2500017
Cahors, France
Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
Chambéry, France
Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012
Essey-lès-Nancy, France
Centre Hospitalier Le Mans - Investigational Site Number : 2500015
Le Mans, France
Investigational Site Number : 2500013
Lille, France
Investigational Site Number : 2500004
Montpellier, France
Investigational Site Number : 2500009
Pessac, France
CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
Poitiers, France
CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
Reims, France
Investigational Site Number : 2500001
Rouen, France
Investigational Site Number : 2500005
Saint-Priest-en-Jarez, France
Investigational Site Number : 2500014
Saint-Quentin, France
Investigational Site Number : 2500016
Tarbes, France
Investigational Site Number : 2500011
Vannes, France
Investigational Site Number : 2760016
Aschaffenburg, Germany
Investigational Site Number : 2760020
Bamberg, Germany
Investigational Site Number : 2760018
Bayreuth, Germany
Investigational Site Number : 2760003
Berlin, Germany
Investigational Site Number : 2760041
Berlin, Germany
Praxis am Volkspark - Investigational Site Number : 2760009
Berlin, Germany
Investigational Site Number : 2760022
Berlin, Germany
MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
Cologne, Germany
Investigational Site Number : 2760007
Donauwörth, Germany
GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
Dortmund, Germany
Investigational Site Number : 2760002
Dresden, Germany
Investigational Site Number : 2760035
Dresden, Germany
Investigational Site Number : 2760037
Frankfurt, Germany
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010
Frankfurt am Main, Germany
Investigational Site Number : 2760012
Hanover, Germany
Investigational Site Number : 2760013
Herrsching am Ammersee, Germany
Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026
Kulmbach, Germany
Investigational Site Number : 2760008
Leipzig, Germany
Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038
Marburg, Germany
Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
Mutlangen, Germany
Investigational Site Number : 2760006
München, Germany
Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
Neubrandenburg, Germany
Investigational Site Number : 2760021
Oldenburg, Germany
Investigational Site Number : 2760036
Oldenburg, Germany
Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
Potsdam, Germany
Investigational Site Number : 2760040
Stolberg, Germany
Investigational Site Number : 2760031
Weilheim, Germany
Investigational Site Number : 2760019
Würzburg, Germany
Investigational Site Number : 3000005
Piraeus, Greece
Investigational Site Number : 3440001
Hong Kong, Hong Kong
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002
Rome, Roma, Italy
Investigational Site Number : 3800006
Bari, Italy
Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
Bologna, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
Brescia, Italy
Investigational Site Number : 3800003
Milan, Italy
Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001
Naples, Italy
Investigational Site Number : 3800008
Novara, Italy
Investigational Site Number : 3800013
Pavia, Italy
Investigational Site Number : 3800004
Trento, Italy
Investigational Site Number : 3800010
Treviso, Italy
Investigational Site Number : 3920012
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920009
Osaka, Osaka, Japan
Investigational Site Number : 3920003
Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004
Minato-ku, Tokyo, Japan
Investigational Site Number : 3920010
Fukuoka, Japan
Investigational Site Number : 3920013
Minatoku, Japan
Investigational Site Number : 3920005
Okayama, Japan
Investigational Site Number : 3920014
Osakasayama-shi, Japan
Investigational Site Number : 3920008
Shibukawa-shi, Japan
Investigational Site Number : 3920011
Suwa-shi, Japan