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Spots Global Cancer Trial Database for A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

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Trial Identification

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

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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