Spots Global Cancer Trial Database for Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
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Trial Identification
Brief Title: Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Official Title: Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
Study ID: NCT03275285
Conditions
Study Description
Brief Summary: The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
Detailed Description: The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF MS Center Site Number : 8400002, San Francisco, California, United States
Spartanburg Medical Center Site Number : 8400003, Spartanburg, South Carolina, United States
Investigational Site Number : 0360005, Blacktown, New South Wales, Australia
Investigational Site Number : 0360006, Tweed Heads, New South Wales, Australia
Investigational Site Number : 0360002, Wollongong, New South Wales, Australia
Investigational Site Number : 0360001, Fitzroy, Victoria, Australia
Investigational Site Number : 0360004, Heidelberg West, Victoria, Australia
Investigational Site Number : 0360007, Nedlands, Western Australia, Australia
Investigational Site Number : 0360008, West Perth, Western Australia, Australia
Hospital Sao Rafael Site Number : 0760005, Salvador, Bahia, Brazil
Hospital Mae de Deus Site Number : 0760003, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001, Barretos, São Paulo, Brazil
Hospital das Clinicas de Sao Paulo Site Number : 0760002, Sao Paulo, São Paulo, Brazil
Instituto COI de Educacao e Pesquisa Site Number : 0760004, Rio De Janeiro, , Brazil
Investigational Site Number : 1240003, Surrey, British Columbia, Canada
Investigational Site Number : 1240001, Saint John, New Brunswick, Canada
Investigational Site Number : 1240002, Montreal, Quebec, Canada
Investigational Site Number : 2030002, Brno, , Czechia
Investigational Site Number : 2030004, Olomouc, , Czechia
Investigational Site Number : 2030003, Ostrava - Poruba, , Czechia
Investigational Site Number : 2030001, Praha 2, , Czechia
Investigational Site Number : 2500003, Lille, , France
Investigational Site Number : 2500001, Nantes, , France
Investigational Site Number : 2500006, Paris, , France
Investigational Site Number : 2500002, Pessac, , France
Investigational Site Number : 2500005, Pierre Benite, , France
Investigational Site Number : 2500004, POITIERS Cedex, , France
Investigational Site Number : 3000002, Athens, , Greece
Investigational Site Number : 3000005, Athens, , Greece
Investigational Site Number : 3000001, Athens, , Greece
Investigational Site Number : 3000004, Patra, , Greece
Investigational Site Number : 3000003, Thessaloniki, , Greece
Investigational Site Number : 3480003, Budapest, , Hungary
Investigational Site Number : 3480001, Budapest, , Hungary
Investigational Site Number : 3480004, Budapest, , Hungary
Investigational Site Number : 3480005, Kaposvár, , Hungary
Investigational Site Number : 3800003, Bologna, , Italy
Investigational Site Number : 3800001, Pisa, , Italy
Investigational Site Number : 3800004, Reggio Emilia, , Italy
Investigational Site Number : 3800002, Torino, , Italy
Investigational Site Number : 3920005, Shiwa-gun, Iwate, Japan
Investigational Site Number : 3920007, Kumamoto-shi, Kumamoto, Japan
Investigational Site Number : 3920001, Suwa-shi, Nagano, Japan
Investigational Site Number : 3920003, Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920004, Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920006, Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 3920002, Yamagata-shi, , Japan
Investigational Site Number : 4100002, Gangnam-gu, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100005, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100006, Busan, , Korea, Republic of
Investigational Site Number : 5540001, Auckland, , New Zealand
Investigational Site Number : 5540002, Wellington, , New Zealand
Investigational Site Number : 6430002, Ekaterinburg, , Russian Federation
Investigational Site Number : 6430003, Kirov, , Russian Federation
Investigational Site Number : 6430004, Novosibirsk, , Russian Federation
Investigational Site Number : 7240001, Badalona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240005, Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240002, Valencia, Valenciana, Comunidad, Spain
Investigational Site Number : 7240003, Madrid, , Spain
Investigational Site Number : 7240004, Sevilla, , Spain
Investigational Site Number : 7920003, Adana, , Turkey
Investigational Site Number : 7920001, Ankara, , Turkey
Investigational Site Number : 7920005, Bursa, , Turkey
Investigational Site Number : 7920002, Istanbul, , Turkey
Investigational Site Number : 7920004, Samsun, , Turkey
Investigational Site Number : 8260004, Plymouth, Devon, United Kingdom
Investigational Site Number : 8260005, Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260001, Bristol, Somerset, United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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