Spots Global Cancer Trial Database for Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
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Trial Identification
Brief Title: Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Official Title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Study ID: NCT02990338
Conditions
Study Description
Brief Summary: Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: * To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. * To compare the Overall Survival (OS) between the two arms. * To evaluate the Time To Progression (TTP) in each arm. * To evaluate the PFS in high risk cytogenetic population in each arm. * To evaluate the Duration of Response (DOR) in each arm. * To evaluate the safety in both treatment arms. * To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. * To evaluate the immunogenicity of isatuximab. * 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 the participants included a period for screening of up to 21 days (or up to 28 days for women who can become pregnant). Participants continued study treatment until disease progression, unacceptable adverse reaction, participants' wish or other reason of discontinuation. During follow-up, participants who discontinued the study treatment due to progression of the disease were followed every 3 months (12 weeks) for survival (or until cut-off date), and participants who discontinued the study treatment prior to documentation of disease progression were followed-up every 4 weeks until disease progression, and then every 3 months (12 weeks) for survival (or until cut-off date).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
BRCR Medical Center Inc. Site Number : 8400002, Plantation, Florida, United States
Dana Farber Site Number : 8400006, Boston, Massachusetts, United States
Investigational Site Number : 0360004, St Leonards, New South Wales, Australia
Investigational Site Number : 0360001, Waratah, New South Wales, Australia
Investigational Site Number : 0360005, Melbourne, Victoria, Australia
Investigational Site Number : 0360002, Melbourne, Victoria, Australia
Investigational Site Number : 0360006, Richmond, Victoria, Australia
Investigational Site Number : 0560003, Antwerpen, , Belgium
Investigational Site Number : 0560002, Brussel, , Belgium
Investigational Site Number : 0560004, Gent, , Belgium
Investigational Site Number : 0560001, Leuven, , Belgium
Investigational Site Number : 1240001, Montreal, Quebec, Canada
Investigational Site Number : 1240004, Montreal, Quebec, Canada
Investigational Site Number : 1240005, Sherbrooke, Quebec, Canada
Investigational Site Number : 2030005, Brno, , Czechia
Investigational Site Number : 2030004, Hradec Kralove, , Czechia
Investigational Site Number : 2030001, Olomouc, , Czechia
Investigational Site Number : 2030002, Ostrava - Poruba, , Czechia
Investigational Site Number : 2030003, Praha 2, , Czechia
Investigational Site Number : 2080002, Aalborg, , Denmark
Investigational Site Number : 2500021, Bayonne, , France
Investigational Site Number : 2500008, Caen, , France
Investigational Site Number : 2500009, Dijon, , France
Investigational Site Number : 2500017, Grenoble, , France
Investigational Site Number : 2500013, La Roche Sur Yon, , France
Investigational Site Number : 2500003, Lille, , France
Investigational Site Number : 2500023, Limoges, , France
Investigational Site Number : 2500019, Montpellier Cedex, , France
Investigational Site Number : 2500002, Nantes, , France
Investigational Site Number : 2500015, Paris, , France
Investigational Site Number : 2500016, Paris, , France
Investigational Site Number : 2500005, Pessac, , France
Investigational Site Number : 2500004, Pierre Benite, , France
Investigational Site Number : 2500007, POITIERS Cedex, , France
Investigational Site Number : 2500025, Reims, , France
Investigational Site Number : 2500014, Rennes, , France
Investigational Site Number : 2500001, TOULOUSE Cedex 9, , France
Investigational Site Number : 2500012, Tours, , France
Investigational Site Number : 2500018, Vandoeuvre-les-nancy, , France
Investigational Site Number : 2760001, Leipzig, , Germany
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 : 3480001, Budapest, , Hungary
Investigational Site Number : 3480003, Budapest, , Hungary
Investigational Site Number : 3480002, Debrecen, , Hungary
Investigational Site Number : 3800001, Bologna, , Italy
Investigational Site Number : 3800010, Catania, , Italy
Investigational Site Number : 3800009, Firenze, , Italy
Investigational Site Number : 3800008, Genova, , Italy
Investigational Site Number : 3800007, Milano, , Italy
Investigational Site Number : 3800002, Milano, , Italy
Investigational Site Number : 3800006, Padova, , Italy
Investigational Site Number : 3800004, Terni, , Italy
Investigational Site Number : 3800003, Torino, , Italy
Investigational Site Number : 3920001, Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920005, Shibukawa-shi, Gunma, Japan
Investigational Site Number : 3920004, Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920006, Kyoto-shi, Kyoto, Japan
Investigational Site Number : 3920008, Suwa-shi, Nagano, Japan
Investigational Site Number : 3920003, Okayama-shi, Okayama, Japan
Investigational Site Number : 3920007, Shizuoka, Sunto Gun, Japan
Investigational Site Number : 3920002, Shibuya-ku, Tokyo, Japan
Investigational Site Number : 4100007, Hwasun-gun, Jeollanam-do, Korea, Republic of
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100006, Incheon, , Korea, Republic of
Investigational Site Number : 4100005, Seoul, , Korea, Republic of
Investigational Site Number : 5540001, Takapuna, Auckland, New Zealand
Investigational Site Number : 5540004, Dunedin, Otago, New Zealand
Investigational Site Number : 5540003, Hamilton, Waikato, New Zealand
Investigational Site Number : 5540002, Auckland, , New Zealand
Investigational Site Number : 5780001, Oslo, , Norway
Investigational Site Number : 6160003, Lublin, Lubuskie, Poland
Investigational Site Number : 6160005, Krakow, Malopolskie, Poland
Investigational Site Number : 6160001, Warszawa, Mazowieckie, Poland
Investigational Site Number : 6160002, Chorzow, Slaskie, Poland
Investigational Site Number : 6200004, Coimbra, , Portugal
Investigational Site Number : 6200002, Lisboa, , Portugal
Investigational Site Number : 6200001, Porto, , Portugal
Investigational Site Number : 6430004, Moscow, , Russian Federation
Investigational Site Number : 6430001, Moscow, , Russian Federation
Investigational Site Number : 6430002, Moscow, , Russian Federation
Investigational Site Number : 7030001, Bratislava, , Slovakia
Investigational Site Number : 7240005, Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240001, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006, Santander, Cantabria, Spain
Investigational Site Number : 7240002, Pamplona, Navarra, Spain
Investigational Site Number : 7240003, Madrid, , Spain
Investigational Site Number : 7240004, Salamanca, , Spain
Investigational Site Number : 7520004, Luleå, , Sweden
Investigational Site Number : 7520005, Uddevalla, , Sweden
Investigational Site Number : 1580004, Kaohsiung, , Taiwan
Investigational Site Number : 1580002, Taichung, , Taiwan
Investigational Site Number : 1580001, Taipei, , Taiwan
Investigational Site Number : 1580003, Taoyuan, , Taiwan
Investigational Site Number : 7920001, Ankara, , Turkey
Investigational Site Number : 7920002, Antalya, , Turkey
Investigational Site Number : 7920005, Istanbul, , Turkey
Investigational Site Number : 7920006, Istanbul, , Turkey
Investigational Site Number : 7920003, Istanbul, , Turkey
Investigational Site Number : 7920004, Istanbul, , Turkey
Investigational Site Number : 7920008, Izmir, , Turkey
Investigational Site Number : 7920010, Izmir, , Turkey
Investigational Site Number : 7920009, Kayseri, , Turkey
Investigational Site Number : 7920007, Kocaeli, , Turkey
Investigational Site Number : 8260002, London, London, City Of, United Kingdom
Investigational Site Number : 8260003, London, London, City Of, United Kingdom
Investigational Site Number : 8260001, London, London, City Of, United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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