Spots Global Cancer Trial Database for A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
Official Title: A Phase 3 Randomized, Open Label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
Study ID: NCT04270409
Conditions
Study Description
Brief Summary: Primary Objectives: * Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in * To assess overall response rate (ORR) * To assess duration of response (DOR) * To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) * To assess time to diagnostic (SLiM CRAB) progression or death * To assess time to first-line treatment for multiple myeloma (MM) * To assess the potential immunogenicity of isatuximab * Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms * MRD negativity * Sustained MRD negativity * Second progression-free survival (PFS2) * Overall survival Other Secondary Objectives: To evaluate in both arms * CR rate * ORR * DOR * Time to diagnostic (SLiM CRAB) progression * Time to biochemical progression * Time to first-line treatment for MM * Safety and tolerability * Pharmacokinetics (PK) * Potential of isatuximab immunogenicity * Clinical outcome assessments (COAs)
Detailed Description: Study duration is expected to be approximately 12 years, including a 42-day screening period, followed by an up to 36-month treatment period, and a follow-up period of approximately 9 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
UCLA Site Number : 8400010, Los Angeles, California, United States
Colorado Blood Cancer Institute Site Number : 8400007, Denver, Colorado, United States
Cancer Specialist of North Florida Site Number : 8400011, Jacksonville, Florida, United States
University of Miami Site Number : 8400012, Miami, Florida, United States
Dana Farber Cancer Institute Site Number : 8400001, Boston, Massachusetts, United States
Presbyterian Hospital Site Number : 8400015, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center Site Number : 8401015, Winston-Salem, North Carolina, United States
Tennessee Oncology Site Number : 8400006, Nashville, Tennessee, United States
~University of Texas - MD Anderson Cancer Center Site Number : 8400002, Houston, Texas, United States
Investigational Site Number :0360008, Liverpool, New South Wales, Australia
Investigational Site Number :0360005, Waratah, New South Wales, Australia
Investigational Site Number :0360001, Wollongong, New South Wales, Australia
Investigational Site Number :0360002, Fitzroy, Victoria, Australia
Investigational Site Number :0360007, Heidelberg West, Victoria, Australia
Investigational Site Number :0360004, Richmond, Victoria, Australia
Investigational Site Number :0360006, Nedlands, Western Australia, Australia
Investigational Site Number :0760002, Sao Paulo, São Paulo, Brazil
Investigational Site Number :1240004, Edmonton, Alberta, Canada
Investigational Site Number :1240005, Moncton, New Brunswick, Canada
Investigational Site Number :1240001, Montreal, Quebec, Canada
Investigational Site Number :1560002, Hangzhou, , China
Investigational Site Number :1560003, Hangzhou, , China
Investigational Site Number :1560006, Nanchang, , China
Investigational Site Number :1560004, Shanghai, , China
Investigational Site Number :1560005, Shenyang, , China
Investigational Site Number :1560001, Tianjin, , China
Investigational Site Number : 2030004, Brno, , Czechia
Investigational Site Number : 2030005, Hradec Kralove, , Czechia
Investigational Site Number : 2030002, Olomouc, , Czechia
Investigational Site Number : 2030003, Ostrava - Poruba, , Czechia
Investigational Site Number : 2030001, Praha 2, , Czechia
Investigational Site Number :2080001, Aalborg, , Denmark
Investigational Site Number :2080003, Aarhus N, , Denmark
Investigational Site Number :2080005, Copenhagen, , Denmark
Investigational Site Number :2080002, Roskilde, , Denmark
Investigational Site Number :2500009, Ars-Laquenexy, , France
Investigational Site Number :2500010, Bayonne, , France
Investigational Site Number :2500007, GRENOBLE Cedex 9, , France
Investigational Site Number :2500006, La Roche sur Yon, , France
Investigational Site Number :2500003, Lille, , France
Investigational Site Number :2500005, Paris, , France
Investigational Site Number :2500011, Paris, , France
Investigational Site Number :2500002, Poitiers Cedex, , France
Investigational Site Number :2500001, RENNES Cedex 09, , France
Investigational Site Number :2760001, Hamburg, , Germany
Investigational Site Number :2760002, Heidelberg, , Germany
Investigational Site Number :3000002, Athens, , Greece
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :3000003, Thessaloniki, , Greece
Investigational Site Number :3480003, Budapest, , Hungary
Investigational Site Number :3480001, Budapest, , Hungary
Investigational Site Number :3480002, Debrecen, , Hungary
Investigational Site Number :3480004, Kaposvár, , Hungary
Investigational Site Number :3720003, Dublin 7, Dublin, Ireland
Investigational Site Number :3720002, Dublin 8, Dublin, Ireland
Investigational Site Number :3720001, Dublin 9, Dublin, Ireland
Investigational Site Number :3760004, Ashdod, , Israel
Investigational Site Number :3760001, Jerusalem, , Israel
Investigational Site Number :3760002, Jerusalem, , Israel
Investigational Site Number :3760005, Petah-Tikva, , Israel
Investigational Site Number :3760006, Ramat Gan, , Israel
Investigational Site Number :3760003, Tel Aviv, , Israel
Investigational Site Number :3800006, Meldola, Forlì-Cesena, Italy
Investigational Site Number :3800001, Rozzano, Milano, Italy
Investigational Site Number :3800005, Ancona, , Italy
Investigational Site Number :3800003, Bologna, , Italy
Investigational Site Number :3800002, Terni, , Italy
Investigational Site Number :3920002, Nagoya-shi, Aichi, Japan
Investigational Site Number :3920006, Kamogawa-shi, Chiba, Japan
Investigational Site Number :3920008, Maebashi-shi, Gunma, Japan
Investigational Site Number :3920005, Higashiibaraki-gun, Ibaraki, Japan
Investigational Site Number :3920003, Okayama-shi, Okayama, Japan
Investigational Site Number :3920009, Sunto-gun, Shizuoka, Japan
Investigational Site Number :3920001, Shibuya-ku, Tokyo, Japan
Investigational Site Number :4100004, Gangnam-gu, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100002, Seoul, , Korea, Republic of
Investigational Site Number :4400001, Vilnius, , Lithuania
Investigational Site Number :5540004, Christchurch, Canterbury, New Zealand
Investigational Site Number :5540001, Hamilton, Waikato, New Zealand
Investigational Site Number :5780002, Bergen, , Norway
Investigational Site Number :5780001, Oslo, , Norway
Investigational Site Number :6160006, Bydgoszcz, Kujawsko-pomorskie, Poland
Investigational Site Number :6160002, Lodz, Lódzkie, Poland
Investigational Site Number :6160008, Gdansk, Pomorskie, Poland
Investigational Site Number :6160005, Chorzow, Slaskie, Poland
Investigational Site Number :7240004, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240001, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240006, Pamplona, Navarra, Spain
Investigational Site Number :7240002, Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240005, Madrid, , Spain
Investigational Site Number :7240007, Salamanca, , Spain
Investigational Site Number :7240003, Zaragoza, , Spain
Investigational Site Number :7520001, Göteborg, , Sweden
Investigational Site Number :7520003, Helsingborg, , Sweden
Investigational Site Number : 7920005, Ankara, , Turkey
Investigational Site Number : 7920001, Ankara, , Turkey
Investigational Site Number : 7920004, Istanbul, , Turkey
Investigational Site Number : 7920002, Istanbul, , Turkey
Investigational Site Number : 7920003, Izmir, , Turkey
Investigational Site Number :8260002, Bournemouth, Hampshire, United Kingdom
Investigational Site Number :8260003, London, London, City Of, United Kingdom
Investigational Site Number :8260001, Leicester, , United Kingdom
Investigational Site Number :8260004, Southampton, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
