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Brief Title: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Official Title: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study ID: NCT04458831
Brief 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
Detailed Description: Duration per participant is 2.5 years
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint Petersburg, Florida, United States
Central Care Cancer Center Site Number : 8400006, Garden City, Kansas, 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
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, 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 de Buenos Aires, Buenos Aires, Argentina
Investigational Site Number : 0320004, Buenos Aires, , Argentina
Investigational Site Number : 0320002, Cordoba, , Argentina
LKH Steyr - Investigational Site Number : 0400002, Steyr, , Austria
Investigational Site Number : 0400003, Wien, , 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
Investigational Site Number : 2500012, Essey les Nancy, , France
Centre Hospitalier Le Mans - Investigational Site Number : 2500015, Le Mans Cedex, , France
Investigational Site Number : 2500013, Lille, , France
Investigational Site Number : 2500004, Montpellier Cedex 5, , France
Investigational Site Number : 2500009, Pessac cedex, , 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 cedex, , France
Investigational Site Number : 2500016, Tarbes, , France
Investigational Site Number : 2500003, Toulouse, , France
Investigational Site Number : 2500011, Vannes Cedex, , France
Investigational Site Number : 2760014, Aschaffenburg, , Germany
Investigational Site Number : 2760016, Aschaffenburg, , Germany
Investigational Site Number : 2760025, Bad Liebenwerda, , Germany
Investigational Site Number : 2760017, Baden-Baden, , 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
Investigational Site Number : 2760007, Donauwoerth, , 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 : 2760010, Frankfurt am Main, , Germany
Investigational Site Number : 2760037, Frankfurt, , Germany
Investigational Site Number : 2760015, Goslar, , Germany
Investigational Site Number : 2760012, Hannover, , Germany
Investigational Site Number : 2760013, Herrsching, , Germany
MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034, Koeln, , Germany
Investigational Site Number : 2760026, Kulmbach, , Germany
Investigational Site Number : 2760008, Leipzig, , Germany
Investigational Site Number : 2760011, Magdeburg, , Germany
Investigational Site Number : 2760038, Marburg, , Germany
Investigational Site Number : 2760006, Muenchen, , Germany
Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042, Mutlangen, , 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, Wuerzburg, , Germany
Investigational Site Number : 3440001, Hong Kong, , Hong Kong
Investigational Site Number : 3800009, Rome, Roma, Italy
Investigational Site Number : 3800002, Rome, Roma, 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
Investigational Site Number : 3800001, Napoli, , Italy
Investigational Site Number : 3800008, Novara, , Italy
Investigational Site Number : 3800010, Treviso, , Italy
Investigational Site Number : 3920012, Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920009, Osaka-shi, Osaka, Japan
Investigational Site Number : 3920003, Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004, Minato-ku, Tokyo, Japan
Investigational Site Number : 3920006, Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920010, Fukuoka-shi, , Japan
Investigational Site Number : 3920002, Kamogawa-shi, , Japan
Investigational Site Number : 3920007, Kashiwa-shi, , Japan
Investigational Site Number : 3920013, Minato-ku, , Japan
Investigational Site Number : 3920005, Okayama-shi, , Japan
Investigational Site Number : 3920014, Osakasayama-shi, , Japan
Investigational Site Number : 3920008, Shibukawa-shi, , Japan
Investigational Site Number : 3920011, Suwa-shi, , Japan
Investigational Site Number : 3920001, Yamagata-shi, , Japan
Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001, Dordrecht, , Netherlands
Puerto Rico Medical Research Center, LLC Site Number : 8400001, Hato Rey, , Puerto Rico
Auxilio Mutuo Cancer Center Site Number : 8400029, San Juan, , Puerto Rico
Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005, Leon, León, Spain
Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006, Malaga, Málaga, Spain
Investigational Site Number : 7240009, Pamplona, Navarra, Spain
Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010, Granada, , Spain
Hospital Universitari Son Espases - Investigational Site Number : 7240003, Palma de Mallorca, , Spain
Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011, Pontevedra, , Spain
omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007, San Cristobal De La Laguna, , Spain
Investigational Site Number : 7240004, Toledo, , Spain
Investigational Site Number : 5760003, Baden, , Switzerland
Investigational Site Number : 5760001, Bern, , Switzerland
Stadtspital Triemli - Investigational Site Number : 5760002, Zürich, , Switzerland
Investigational Site Number : 1580002, Kaohsiung, , Taiwan
Investigational Site Number : 7840002, Abu Dhabi, , United Arab Emirates
Investigational Site Number : 7840001, Abu dhabi, , United Arab Emirates
Investigational Site Number : 8260002, Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260005, Sutton, Surrey, United Kingdom
Investigational Site Number : 8260004, Huddersfield, , United Kingdom
Freeman Hospital - Investigational Site Number : 8260003, Newcastle Upon Tyne, , United Kingdom
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR