Spots Global Cancer Trial Database for Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
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Trial Identification
Brief Title: Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant
Official Title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Study ID: NCT03319667
Conditions
Study Description
Brief Summary: Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in patients with CR. * Very good partial response or better rate, as defined by the IMWG criteria. * Overall survival (OS). * To evaluate the overall response rate (ORR) as per IMWG criteria. * To evaluate the time to progression (TTP) overall and by MRD status. * To evaluate PFS by MRD status. * To evaluate the duration of response (DOR) overall and by MRD status. * To evaluate time to first response (TT1R). * To evaluate time to best response (TTBR). * To evaluate progression-free survival on next line of therapy (PFS2). * To evaluate the sustained MRD negativity \>12 months rate. * To evaluate safety. * To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). * To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms). * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
Detailed Description: The duration of the study for each patient will include a screening period of up to 4 weeks, an induction period of 24 weeks (4 cycles with a duration of 42 ± 3 days), a continuous treatment period and a crossover period (when applicable). The cycle duration is 28 ± 3 days during the continuous treatment and crossover periods.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :8400006, Fort Myers, Florida, United States
Investigational Site Number :8400004, Saint Petersburg, Florida, United States
Investigational Site Number :8400007, Kansas City, Missouri, United States
Investigational Site Number :8400005, Nashville, Tennessee, United States
Investigational Site Number :8400001, Houston, Texas, United States
Investigational Site Number :0360003, Liverpool, New South Wales, Australia
Investigational Site Number :0360001, Waratah, New South Wales, Australia
Investigational Site Number :0360002, Wollongong, New South Wales, Australia
Investigational Site Number :0360007, South Brisbane, Queensland, Australia
Investigational Site Number :0360005, Clayton, Victoria, Australia
Investigational Site Number :0360004, Heidelberg West, Victoria, Australia
Investigational Site Number :0360006, Nedlands, Western Australia, Australia
Investigational Site Number :0360008, West Perth, Western Australia, Australia
Investigational Site Number :0560001, Liège, , Belgium
Investigational Site Number :1560002, Beijing, , China
Investigational Site Number :1560003, Beijing, , China
Investigational Site Number :1560008, Changchun, , China
Investigational Site Number :1560007, Fuzhou, , China
Investigational Site Number :1560009, Guangzhou, , China
Investigational Site Number :1560006, Guangzhou, , China
Investigational Site Number :1560005, Hangzhou, , China
Investigational Site Number :1560014, Hangzhou, , China
Investigational Site Number :1560004, Nanjing, , China
Investigational Site Number :1560013, Shanghai, , China
Investigational Site Number :1560011, Shenyang, , China
Investigational Site Number :1560001, Tianjin, , China
Investigational Site Number :1560012, Wuhan, , China
Investigational Site Number :2030002, Brno, , Czechia
Investigational Site Number :2030007, Hradec Kralove, , Czechia
Investigational Site Number :2030004, Olomouc, , Czechia
Investigational Site Number :2030003, Ostrava - Poruba, , Czechia
Investigational Site Number :2030006, Plzen, , Czechia
Investigational Site Number :2030001, Praha 2, , Czechia
Investigational Site Number :2080002, Aalborg, , Denmark
Investigational Site Number :2080003, Aarhus N, , Denmark
Investigational Site Number :2080004, Odense C, , Denmark
Investigational Site Number :2500011, Bayonne, , France
Investigational Site Number :2500007, Caen, , France
Investigational Site Number :2500009, Dijon, , France
Investigational Site Number :2500008, La Roche Sur Yon, , France
Investigational Site Number :2500001, Lille, , France
Investigational Site Number :2500003, Nantes, , France
Investigational Site Number :2500012, Paris, , France
Investigational Site Number :2500002, Pessac, , France
Investigational Site Number :2500006, Pierre Benite, , France
Investigational Site Number :2500005, Poitiers Cedex, , France
Investigational Site Number :2500004, TOULOUSE Cedex 9, , France
Investigational Site Number :2500010, Vandoeuvre-les-nancy, , France
Investigational Site Number :2760003, Berlin, , Germany
Investigational Site Number :2760004, Frankfurt am Main, , Germany
Investigational Site Number :2760001, Heidelberg, , Germany
Investigational Site Number :2760005, Tübingen, , Germany
Investigational Site Number :3000003, Athens, , Greece
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :3000002, Thessaloniki, , Greece
Investigational Site Number :3800005, Ancona, , Italy
Investigational Site Number :3800003, Bergamo, , Italy
Investigational Site Number :3800001, Bologna, , Italy
Investigational Site Number :3800004, Brescia, , Italy
Investigational Site Number :3800002, Torino, , Italy
Investigational Site Number :3920007, Nagoya-shi, Aichi, Japan
Investigational Site Number :3920004, Higashiibaraki-gun, Ibaraki, Japan
Investigational Site Number :3920008, Konan-ku, Yokohama-shi, Kanagawa, Japan
Investigational Site Number :3920003, Kumamoto-shi, Kumamoto, Japan
Investigational Site Number :3920009, Sendai-shi, Miyagi, Japan
Investigational Site Number :3920005, Okayama-shi, Okayama, Japan
Investigational Site Number :3920006, Sunto-gun, Shizuoka, Japan
Investigational Site Number :3920001, Shibuya-ku, Tokyo, Japan
Investigational Site Number :3920002, Shinjuku-ku, Tokyo, Japan
Investigational Site Number :3920010, Yamagata-shi, , Japan
Investigational Site Number :4400002, Klaipeda, , Lithuania
Investigational Site Number :4400001, Vilnius, , Lithuania
Investigational Site Number :4840001, Monterrey, Nuevo León, Mexico
Investigational Site Number :5540002, Takapuna, Auckland, New Zealand
Investigational Site Number :5540003, Hamilton, Waikato, New Zealand
Investigational Site Number :5540001, Auckland, , New Zealand
Investigational Site Number :6160003, Lodz, Lódzkie, Poland
Investigational Site Number :6160001, Warszawa, Mazowieckie, Poland
Investigational Site Number :6160002, Gdansk, Pomorskie, Poland
Investigational Site Number :6160004, Poznan, Wielkopolskie, Poland
Investigational Site Number :6200002, Braga, , Portugal
Investigational Site Number :6200006, Coimbra, , Portugal
Investigational Site Number :6200001, Lisboa, , Portugal
Investigational Site Number :6200005, Porto, , Portugal
Investigational Site Number :6200003, Porto, , Portugal
Investigational Site Number :6430001, Moscow, , Russian Federation
Investigational Site Number :6430002, Moscow, , Russian Federation
Investigational Site Number :7240005, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240004, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240003, Madrid, , Spain
Investigational Site Number :7240001, Murcia, , Spain
Investigational Site Number :7520002, Lund, , Sweden
Investigational Site Number :7520001, Stockholm, , Sweden
Investigational Site Number :1580003, Changhua, , Taiwan
Investigational Site Number :1580002, Taichung, , Taiwan
Investigational Site Number :1580001, Taipei, , Taiwan
Investigational Site Number :7920006, Adana, , Turkey
Investigational Site Number :7920007, Ankara, , Turkey
Investigational Site Number :7920001, Ankara, , Turkey
Investigational Site Number :7920002, Istanbul, , Turkey
Investigational Site Number :7920004, Izmir, , Turkey
Investigational Site Number :7920003, Izmir, , Turkey
Investigational Site Number :7920005, Kayseri, , Turkey
Investigational Site Number :7920008, Samsun, , Turkey
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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